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Our Jobs Page Manager is Geoff Hunt
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Please contact me with any job page related questions or comments. Also contact me for more information regarding the San Diego Quality Professional's Job Hunting Network, their meeting schedule, and network opportunities. Jobs kept active for approximately two to three months. |
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Un-employed Member Profiles in Reverse Chronological Order
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Employers: Thanks for highlighting the importance of ASQ certifications in your job ads. We charge $25 per ad for recruiters, agencies, and or non-local companies unless they specifically ask for ASQ certifications. All other ads placed by local companies will be posted free of charge.
Ads below are in reverse chronological order and saved for approximately 2 months. |
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June 29, 2009 San Diego, CA AD: 764 |
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Job Title:
QUALITY INSPECTOR
This position will begin in San Diego and will relocate to Oceanside in the Fall. The qualified Inspector will operate coordinate measurement machines (CMM) and other automated measurement equipment to perform automated inspections of fabricated parts. Additionally, this person will report the results of inspections based on product drawings and specifications and by performing various dimensional and visual inspections of materials and products. In this role, the Quality Inspector will: * Operate coordinate measurement machines (CMM) to perform inspections * Set-up and perform mechanical and electronic dimensional inspection of numerous products * Perform in-process and final visual inspection on multiple product lines * Set-up and operate air gage equipment to perform measurements * Calibrate mechanical and electronic inspection equipment * Analyze and report inspection results * Perform various laboratory tests including surface roughness and hardness testing * Perform routine maintenance of equipment and tooling, preventive maintenance and maintain cleanliness of equipment * Lead the development of new methods and techniques to improve processes and quality of products. * Independently perform development activities to establish methods in order to produce required product and material quality The qualified Quality Inspector will possess: * High school diploma or equivalent. * 2+ years' relevant experience including experience measuring components with manual dimensional measurement devices. * Proven ability to read blueprints * Experience with Surface Plate measurements * Ability to operate a CMM (programming experience is a plus, but not required) * Ability to pass a drug screen and background check * ASQ Certification a plus
Please email your resume to info@simplybiotech.com or call 858.487.0507. More information can be found at www.simplybiotech.com
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June 25, 2009 San Marcos, CA AD: 763 8, 2009 San Marcos, CA AD: 763 |
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Job Title: Quality Inspector
Full time position in San Marcos
Company: Piercan USA, see http://www.piercanusa.com/
Contact: Lynn at la@piercanusa.com or call 760-599-4543
See map and other contact information at http://www.piercanusa.com/contact_information.htm
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June 27, 2009 San Diego, CA AD: 762 |
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Job Title:
Quality Assurance EngineerRequirements: Bachelors of Science in Electrical Engineering or equivalent field. 5 or more years related experience working in quality / program office as it relates to supply of spacecraft level, high reliability electronic components.
Proven track record in providing excellent customer service and a commitment to quality. Background and solid knowledge of MIL specifications and associated test methods for electrical, electronic and electro-mechanical components used in spacecraft applications. General knowledge of electronic and mechanical theory as well as a working knowledge of ISO9001 / AS9100 standards is a plus. Excellent communication skills, verbal and written. Team Oriented. Candidate must have demonstrated quality experience with space and MIL level electronic components
Contact Corey
Roseleip TLC Staffing corey@tlcstaffing.com
858-569-6260
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June 26, 2009 San Diego, CA AD: 761 |
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Job Title:
QC SUPERVISORSimply Biotech specializes in recruiting exclusively for San Diego's biotech community. We are currently seeking a QC Supervisor for a leading and growing San Diego biotech firm. The qualified candidate will be a motivated QC Professional with a desire to grow and learn. In this role, the QC Supervisor will be responsible for supervising all document review and release activities associated with incoming raw materials, intermediates, components, and finished goods in order to ensure timely product release. Additionally, the QC Supervisor will be responsible for maintaining GMP compliance in the QC labs. Duties will include: oReview and approval of all testing results/documentation generated by the laboratory, ensuring that all operations are performed with 100% compliance to cGMP/ISO documentation standards. oSupervising Analysts in planning, organizing, performing, evaluating, reporting, storing and accessing results and device history records for incoming raw materials, intermediates, components, and finished goods. oHelping to assess the impact of procedural deviations and Out of Specification laboratory incidents. This includes providing recommendations/implementations of corrective/preventative actions and promptly conducting investigations of unexpected test results in order to meet testing deadlines. oEstablishing training requirements as well as developing, administering, and monitoring training program. oWriting and updating quality control test procedures and systems to ensure continuous quality improvement. oEvaluating validated analytical methods and procedures to optimize Laboratory testing cycle time. oSupporting the introduction and validation of new testing methods and new products. oRepresenting the department on project teams and may represent the department in the absence of the department manager. The qualified QC Supervisor will possess the following: * BS/BA degree, preferably in BioChemistry or related * 5+ years related experience * 1+ year supervisory experience including: hiring, training, conducting performance reviews, etc For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507. More information can be found at www.simplybiotech.com
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June 25, 2009 San Diego, CA AD: 760 |
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Job Title: Quality Engineer
San Clemente paying up to $100,000 annualy...
Determining, implementing and improving the evolution of The Medical business segment, and its impact on both the strategic and daily product development and operations groups. JOB REQUIREMENTS: Education and Experience: Bachelor degree required, in a technical field, electrical engineering or mechanical engineering. 2-5 years experience in Quality Systems in Medical Device products and high volume manufacturing environments. Auditing experience and certification strongly preferred. CRE, CQE (ASQ) Knowledge/Skills: Quality Tools - Sampling Plans / Problem Solving / Statistical Process Control / ISO 13485/ FMEA, Reliability planning and assessment of products, MTBF, Product life-cycle, design evaluation, Probability distributions, etc. Communication Skills - ability to communicate effectively with all levels of employees throughout the organization. Able to develop and maintain strong working relationships with internal and external customers and suppliers. Project management, multiple tasking and excellent prioritization skills. Computer skills - proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc. Knowledge of quality systems and regulations for medical device industry. Strong Problem Solving Skills
Contact Damian Christiansen T. 619-686-5204 or email dchristiansen@topsstaffing.com
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June 24, 2009 San Diego, CA AD: 75 June 24, 2009 San Diego, CA AD: 759 |
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Job Title: Director of Software QA
Long term position for a company in San Diego, CA.
Contact Angela Tevis at atevis@kforce.com
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June 22, 2009 San Diego, CA AD: 758 |
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Job Title: Project Assistant - Part-time
Location: La Jolla, CA Duration: 6+ months Job Description: Part-time 20-30/hrs /wk Students considered.
Exposure to the daily operations of the chemistry/biology outsourcing.
Contact Amit Pandey (973) 993-9383 Ext.266 or amit_pandey@artechinfo.com
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June 20, 2009 San Diego, CA AD: 757 |
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Position: Quality Engineer
Input and guidance to production and new product development. This role requires a mix of working with 1) compliance to current procedures; 2) data analysis of current processes; 3) critical thinking/writing skills for development and documenting improved processes and 4) auditing to the requirements of AS9100 and customer requirements to ensure compliance. The Quality Engineer reports directly to the Quality Manager and works independently with responsibilities involving higher level decision making. Responsibilities " Represent Quality Assurance during New Product Development including planning and design reviews " Work with management on quality planning (both short term and long term) supporting diagnosis of quality problems (both internal and external), corrective and preventive action programs and continuous improvement programs. " Define deliverable QA requirements as input to project plans. " Actively participate in Design Control, including Quality Planning, FMEA, Hazard Analysis and Design Review. " Participate in MRB meetings (purchased materials and in-house manufactured product), identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems and to improve overall quality (vendors and manufacturing). " Work with Receiving Inspection to utilize standard statistically sound tolerance techniques to determine product acceptance, evaluate process capabilities, and developing statistical sound tolerance limits based on product specifications. " Assist in the development, validation and refining of QA Test and Inspection procedures. " Assist in selecting and acquiring equipment/tooling as required. " Perform internal audits as a lead auditor as assigned " Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment. " Provide technical guidance and training to other team members in statistical analysis techniques, data analysis, sampling techniques and other traditional QA Engineering areas of expertise. " Actively participate in the Lean Enterprise program. Knowledge, Skills and Requirements " BS degree in scientific or quality discipline " A minimum of 3 years of experience in a manufacturing environment. " ASQ certifications received or in process of being received " Strong written / verbal communication and presentation skills. " Experience with Excel, MS Word, PowerPoint, and Statistics applications. " Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies. ISO/AS9100 system knowledge and application/auditing experience. " Demonstrated collaboration, negotiation and conflict resolution skills. " Ability to multi-task and handle tasks with competing priorities effectively. " Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others. " Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information and communicating priorities clearly and concisely. " MUST be a United States Citizen or have current Green Card Status. "
SPARTA Composite Products 10540 Heater Ct. San Diego, CA. 92121
Contact:
Eloise Carnell at 858-824-8904 (Direct) or email Eloise.Carnell@cobham.com
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June 19, 2009 San Diego, CA AD: 756 |
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Position:
Quality Control Specialist IThis individual performs QC release of final product in a GMP environment. Performs real time and accelerated stability testing and value assignment. Assists in validation testing and establishing/modifying QC specifications as needed. Performs incoming material inspections and release, as needed. Performs QC functions in a Controlled Environment Room, as needed. Supports the Quality department in continuous improvement activities. Must have the ability to work in a fast paced environment. Will interact with various departments and personnel to accomplish individual and corporate goals. Education/Experience: BS/BA or equivalent experience. Preferred 1-3 years experience in a medical device setting or experience as a medical technologist in a hospital/clinic setting. Knowledge of Quality systems and GMPs is a must
Contact Dawn at website: www.cliniqa.com or email dgast@cliniqa.com
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June 14, 2009 San Diego, CA AD: 755 4, 2009 San Diego, CA AD: 755 |
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Position: Sr. Quality Engineer for Biologics
Company: NuVasive
Responsible for assisting in the development, implementation, and improvement of overall quality systems, including quality standards, test methods, process control techniques, and inspection/testing plans to ensure the quality of biologics (tissue based and synthetic) products and processes. Essential Duties and Responsibilities: 1. Develop quality outputs for DHF and Technical Files such as process/product validations, risk management, suppliers qualifications, quality agreements, quality plans, and inspection documents. Quality Plans for the product development team. Support development of adequate inspection criteria. 2. Ensure compliance with applicable standards (21 CFR 1271 and 820) both at NuVasive and Suppliers. 3. Interface directly with Suppliers to manage corrective actions, rework plans and non- 4. Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products Education and/or
Experience: Requires a bachelor degree in an engineering or science discipline (e.g. BSIE, BSME, or BSBME or Biology). Five years minimum quality assurance/engineering experience in a regulated environment (AATB Standards, 21 CFR Part 1271, QSR, ISO 13485, and the MDD). American Society for Quality Certified Engineer (CQE) desirable. Computer Skills: Proficient and accurate with word processing (Word), spreadsheets (Excel), Outlook, Adobe Acrobat, and Visio.
Apply for this job among 57 other current and related job openings at http://search10.smartsearchonline.com/nuvasive/jobs/
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June 11, 2009 San Diego, CA AD: 754 |
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QA
Software Engineer in San Diego. If you are interested or know someone
who might be, you can give us more details about your experience or refer
someone at http://jobs.accolo.com/17987.
Here you will also find a more detailed job description.
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June 5, 2009 San Diego, CA AD: 753 |
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Position: 09002050 - Senior Engineer, Software Quality
At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. Function: Engineering Family: Software Quality Engineering What Software Quality Engineering contributes to Cardinal Health Designs tests, develops and maintains test plans and test cases. Conducts all forms of testing across a diverse suite of software products, assuring the highest quality products are developed. What is expected of you for success in your role " Applies working knowledge of software quality concepts within the software development lifecycle " Knowledge of systems analysis " Skilled user of test tools for project area responsible " Make recommendations for improvement to tools " Basic familiarity of application domain or functional areas of system " Applies basic knowledge of end user to evaluate usability of applications " Applies in-depth working understanding of standards and methods to comply/enforce the standards in day to day tasking. " Executes complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers " Interprets product design and requirements to engineer test approach and generates test plans and test cases/scripts " Takes on primary ownership for testing of certain area(s) of a system " Conducts complex black box, system-level, functional testing " Creates basic test plans for white box testing " Develops white box test harnesses and tests " Can apply working understanding of the inter-workings of a section or component of the application code under test " Participates in code reviews " Can develop source code (minimum of one language applicable to development environment) as well as do scripting What is expected of you and others at this level in Engineering for functional success " Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces " Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources. " Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices; Accountabilities in this role " Applies comprehensive understanding of concepts within own technical area to design relatively advanced solutions; demonstrates understanding of key business drivers " Serves as an expert within a technical area and educates others on technical issues " Collaborates with all relevant parties to deliver services " Collaborates with internal/external customers and all relevant parties to deliver services " Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue " Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns " Effectively listens to and explains difficult issues; works to establish consensus and alignment among team member " Solves moderately complex problems " Develops or adapts new innovative solutions to complete work for job family; consciously balancing the risk and reward trade-off to achieve operational excellence Qualifications " Bachelor's degree or equivalent experience in related field required " A minimum of 2+ years related work experience required " Ability to work independently and as a member of a team " Experience with Microsoft Visual Basic, .NET, C++ " MS Office including Visio and Project required " Proficient in WebLogic, Oracle 10i, Cognos reporting engine, firewalls, Microsoft Operating systems
Position: 09002042 Senior Analyst, Software Quality
JOB TITLE: Sr. Analyst, Software Quality At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. Function: IT Centers of Expertise Family: Software Quality What Software Quality contributes to Cardinal Health Ensures quality is built into software development products by utilizing a combination of preventative and appraisal methods, at all phases of development, to keep defects from getting into production. What is expected of you for success in your role " Demonstrates working knowledge of software quality concepts. " Demonstrates working knowledge of at least one software quality discipline. " Implements existing software quality strategies on small projects. " Implements existing software quality processes on small projects. " Collects and publishes defined metrics on small projects. What is expected of you and others at this level in IT - Center of Expertise for functional success " Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications. " Jointly develops practical implementation plans that consider cultural sensitivities with other accountable parties. " Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources. " Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices; " Performs assessments and listens to internal/external customers to understand and anticipate their needs and determine their priorities in the context of the overall enterprise. Accountabilities in this role " Applies comprehensive understanding of concepts within own technical area to design relatively advanced solutions; demonstrates understanding of key business drivers " Serves as an expert within a technical area and educates others on technical issues " Collaborates with all relevant parties to deliver services " Collaborates with internal/external customers and all relevant parties to deliver services " Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue " Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns " Effectively listens to and explains difficult issues; works to establish consensus and alignment among team member " Solves moderately complex problems " Develops or adapts new innovative solutions to complete work for job family; consciously balancing the risk and reward trade-off to achieve operational excellence Qualifications " Bachelor's Degree in computer science or related field preferred or equivalent work experience " Minimum 3 years experience " Proficient with a PC - Windows, Word, Excel, e-mail, etc... " Excellent analytical & communications skills " Experience with Microsoft Visual Basic, .NET, C++ " MS Office including Visio and Project required " Proficient in WebLogic, Oracle 10i, Cognos reporting engine, firewalls, Microsoft Operating systems
For both of these, please direct the applicants to the website www.cardinalhealth.com apply. Here are the requisition numbers for each opening to make it easier to find: 09002050 - Senior Engineer, Software Quality 09002042 Senior Analyst, Software Quality
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May 26, 2009 San Diego, CA AD: 751 |
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Position:
Director of Operations
Medical Device Contract Manufacturer -Must have Exposure in"Maquiladora" and speak Spanish Location- San Diego CA area. Director of Operations -Contract Manufacture of Medical Device *Manage 11 direct reports-must have direct management experience! *Provide leadership and direction to high level performing team *Support all BU strategic goals including the attainment of all the financial targets for full P&L operation with direct shipment to customers *Establish, implement, optimize processes and systems in order to improve manufacturing capabilities and efficiencies *Lean Manufacturing and Six Sigma Methodologies
REQUIREMENTS: ~Good understanding and previous experience in "Maquiladora" ~Experience in being the legal representative for a Medical Device company ~Fluent in Spanish and English ~Able and have previous experience in managing large facility ~A leader and well known in the Medical Device industry ~Very strong legal and financial understanding full P&L operation Perks: Work for a company that is becoming very well known in the industry for delivery 95% on time to its clients. Quality, dignity and personal representation is this companies value. Work with the "A" players in OEM supplier industry. This position comes with all the perks and a VERY competitive compensation package! Based in San Diego, CA
Send a word resume to jthompson@tescareers.com Jeff Thompson TES, Inc 440-266-0022 ext 104 Letter Value: 1279A0-7239A
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May 23, 2009 San Diego, CA AD: 750 |
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Position: Regulatory Compliance Associate
In this role, you will assist the Vice President of Regulatory Affairs with maintaining regulatory compliance in a Class II Medical Device manufacturing environment. Duties and Responsibilities (with oversight): " Collaborate with other functional areas to obtain documentation for regulatory purposes, seek expert advice and technical support as required, and ensure accuracy and completeness of all information " Participates in compliance activities, such as internal audits, FDA and Notified Body audits, complaint handling and vendor audits " Assist with preparation and submission of FDA premarket notifications (510k's) " Prepare responses to action letters and other agency requests " Assist in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products " Prepares outlines, summaries, status reports, graphs, charts, tables and other materials, as necessary " Ensures ongoing compliance with customer quality requirements by coordinating annual product testing and facility audits. Requirements: " One to three years of medical device regulatory affairs experience " Strong verbal, written, inter-personal, planning, record keeping, and organizational skills " Strong word processing and database skills
Fax resume to: 760-727-8080 Attn: HR
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May 18, 2009 San Diego, CA AD: 749 |
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Position: Quality Engineer
$60,000 - $85,000
Pease contact: Bill Crean 858 454-6175 Office 858 869-3924 Cell wdcrean@aol.com
Actively support the Quality Engineering department and all associated activities, including receiving inspection, in-process inspection, and finished goods inspection in achieving and exceeding company goals and objectives. Support the administration, implementation, and continuous improvement of the quality systems associated with corrective action, non-conforming materials, and inspection control plans. This individual also supports corporate strategic goals and objectives through internal audits, support of manufacturing operations, quality support of new product development/product improvement projects, and support of manufacturing process improvement projects. The Quality Engineer assists in determining, implementing and improving the evolution of the corporate quality control system, and its impact on both the strategic and daily product development and manufacturing operations. This individual is responsible for supporting the development and implementation of departmental policies and resources into the daily functions that will affect the long-term quality and manufacturing culture and business strategies within the organization. This individual must lead the efforts in resolving varying levels of quality and compliance issues independently and/or in unison within a cross functional team environment to efficiently and effectively eliminate the issue and its cause.
Requirements: " Prefer a B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience. " 5+ years experience in Quality and Manufacturing Systems in Medical Device and high volume manufacturing environments. " Quality Tools - Problem Solving / Statistical Process Control / Process Capability / ISO 9001 / ISO 13485 / Design of Experiments / Sampling Plans. " Communication Skills - Ability to communicate effectively with all levels of employees throughout the organization. Able to develop and maintain strong working relationships with internal and external customers. " Computer skills - proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc. " Project management, multiple tasking and excellent prioritization skills. " Knowledge of quality systems and regulations for medical device industry. " The Quality Engineer should have a results oriented commitment to the continuing evolution of the quality control system within defined regulatory and corporate requirements. This requires a practical, common sense knowledge base and approach in developing, implementing and administrating the quality control system, especially as it relates to technical problem solving, implementation of corrective actions, development of statistical based inspection control plans and supplier management and direct material control. " The individual must be technically knowledgeable with respect to quality systems, regulatory standards, supplier/subcontractor management, manufacturing systems, product development, project management, material flows, and general production principles. The individual is responsible for supporting the implementation and administration of departmental procedures that will affect the long-term quality and manufacturing strategies within the organization. " Auditing experience and certification strongly preferred.
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May 11, 2009 San Diego, CA AD: 748 |
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Position: Quality Assurance Specialist/Engineer
Reports to: Quality Manager Date
Status: Full-time, exempt
This position will be responsible for representing the quality function in routine, day-to-day execution of activities associated with processing of product as well as operating/maintaining the quality system in general. Note: This is not a S/W QA position. Because we are a small company, core responsibilities will vary widely. The perfect candidate would be able to satisfy all of the characteristics/needs listed below (the most critical of which have been identified with an asterisk*). Key Skills/Experience/Qualification/Responsibilities * Attention to detail * Communication (oral and written) * FDA (or similarly) regulated environment * Incoming material release (acceptance paperwork review/approval) * Final product release (DHR review/approval) * Knowledge of attributes/variables sampling plans * Complaint process administration * Corrective/preventive action administration * Nonconforming product control administration * BoM maintenance * ERP/MRP systems * Quality metrics/data analysis and reporting (basic statistics) * Extensive PC usage (Word, Excel, Visio, Power Point) * Analytical thinking Previous exposure to a small/start-up company environment Device history record form design Internal QS auditing Supplier auditing Nonconforming product review/approval Change Order review/approval Quality system procedure development Quality system trainer Document Control Maintenance of standards library Calibration administration Acceptance (inspection/test) process execution Design Verification and/or Process Validation protocol execution Design Verification and/or Process Validation reporting Design Verification and/or Process Validation planning/protocol development Standards interpretation Risk management ESD environment IPC-610 Education Bachelor's degree in technical field (Alternative: Associate's degree in technical field with minimum of 5 years relevant experience) (Alternative: High school diploma with minimum of 10 years relevant experience)
Email careers@triagewireless.com ... no phone calls regarding this position please. See http://www.triagewireless.com/ for more about the company.
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May 8, 2009 San Diego, CA AD: 747 |
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Title: Quality Assurance Lead
Department: MCTSSA
Location: Camp Pendelton
Reports to: COO
Summary This position will provide Qualify Assurance (QA) support to the United States Marine Corp (USMC) Camp Pendelton. The QA Lead will supervise the QA Team and coordinate the QA activities to ensure USMC C4I systems' test documentation and testing meet organizational standards. Essential duties and Responsibilities • Review and evaluate software Test and Evaluation (T&E) documentation against prescribed standards, and provide comments and recommendations to bring documents up to required standards; T&E documents include, but are not limited to, test plans, test procedures, and test reports. • Observe and document test conduct events and provide recommends to improve testing. • Reviews test conduct logs to identify potential issues associated with testing. • Review and make recommendations regarding QA process improvements. • Develop, revise, and verify QA standards. Required Qualifications • Minimum of an active Department of Defense (DoD) Secret Clearance Desired Qualifications • Experience with DoD Test Programs. • Expereince with DoD C4I Systems. • Experience with USMC family of C4I Systems including: Joint Tactical COP Workstation (JTCW), Transition Switch Module (TSM), MAGTF C4I Capability Certification Test (MC3T), Tactical Combat Operations (TCO), Tactical Air Operations Module AN/TYQ-23 (TAOM), JICO Support Systems (JSS), Joint Tactical Information Distribution System (JTIDS), Enhanced Position Locating Reporting Systems (EPLRS), Advanced Field Artillery Tactical Data System (AFATDS), Theater Battle Management Core System (TBMCS). Email resumes to: human_resources@integrits.com Fax to: 858-300-1639
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May 6, 2009 Corona & Orange County AD: 746 |
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QUALITY ENGINEER - CORONA
QUALITY ASSURANCE MANAGER - CORONA
QUALITY ASSURANCE MANAGER - ORANGE COUNTY
QUALITY ENGINEER -ORANGE COUNTY
Please email your resume to info@simplybiotech.com or call 858.487.0507. More information can be found at www.simplybiotech.com.
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May 3, 2009 San Diego, CA AD: 742 |
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Title:
QUALITY ENGINEER / SUPERVISOR The qualified candidate will have a strong quality engineering background in the medical device industry. In this role, the qualified candidate will be responsible for the quality engineering functions and will oversee the QC team (two inspectors). In this position you will work with Manufacturing teams to: * Conduct process improvements * Conduct process validations * Conduct equipment validations * Write and execute protocols * Investigate complaints and non conformances to establish corrective actions * Establish statistical process controls (DOE, sampling, etc), final release The qualified Quality Engineer will possess the following: * BS in Biology (or other Life Science) * 3-5+ years medical device engineering experience * Experience with biologic devices * Knowledge of Design Control * Supervisory experience * ASQ / CQE desired * Sterilization validation and/or clean-room validation a PLUS For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507. More information can be found at www.simplybiotech.com . EOE
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April 29, 2009 San Diego, CA AD: 741 |
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Title:
ASSOCIATE DIRECTOR QUALITY SYSTEMS - pharmaceutical products and diagnostic services. The qualified Associate Director will manage the internal and external audit programs to ensure compliance and will authorize product release for distribution. In this role, the qualified candidate will directly supervise the members of the Quality Systems department. Essential Functions and Responsibilities: * Develops and maintains strong and effective relationships with contract manufacturers, vendors and suppliers * Monitors quality systems and alerts senior management of anticipated quality problems associated with the company's systems, products or services * Provides primary support for management review of the company's products and quality systems for compliance with FDA regulations * Assures satisfactory performance and completion of QA aspects of regulatory and business development tasks/activities including but not limited to clinical trials, supplies, development and approval of Standard Operating Procedures (SOPs), CAPA, deviations, change control, product complaints, annual product review, product labeling review, and product recall. * Supports Quality management in the preparation, conduct, and follow-up activities resulting from interactions with regulatory and accrediting authorities. * Leads the QA/QC due diligence activities in support of anticipated product development and/or acquisitions as applicable. * Interview, hire and train members of the Quality Systems team The qualified Associate Director will possess: - BS or MS in a scientific discipline. 12+ years of industry experience 5+ years of supervisory experience Excellent knowledge with Code of Federal Regulations for pharmaceutical products Diagnostic industry and/or high complexity CLIA/CAP experience preferred For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507. More information can be found at www.simplybiotech.com.
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April 26, 2009 San Diego, CA AD: 740 |
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Title:
SR. QUALITY ENGINEERLeading medical device firm in North County. The Sr. QE will be responsible for providing quality engineering support in the design and development of medical device products and facilitating the application of design controls. The qualified candidate will be responsible for translating quality standards into processes and procedures and applying these to the new product design process. The qualified candidate will have a strong quality engineering background in the medical device industry and be a self-directed team player and will work with the team to: * Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product requirements. * Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation. * Ensure successful transfer of new products to production facility. Review production processes for quality of validation. * Review and approve verification and validation test plans. Ensure verification / validation results demonstrate compliance to medical device standards. * Provide training to project teams on verification/validation, statistical methods and design controls. * Lead product risk assessment efforts within product teams. * Review Design History Files and Technical Files for conformance to applicable requirements. * Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues. * Conduct internal quality system and supplier quality audits The qualified Quality Engineer will possess the following: Engineering degree (EE preferred) * 5+ years Medical Device QE experience * Experience with design controls and design review * Strong skills in test plan development and root cause failure analysis * Strong skills in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments * Familiarity with reliability analysis and test methods * Familiarity with ISO 14971, or strong experience in risk evaluation techniques, such as FMEA and/or fault tree analysis * CQE certification preferred For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507. More information can be found at www.simplybiotech.com . EOE
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April 23, 2009 San Diego, CA AD: 737-39 |
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Title: Team Leader, Project Manager, Sr. Scientist
Three related positions with the Bioscience Division of EMD Chemicals is a leading supplier of high purity chemicals, research reagents and specialty products for laboratory applications. Products are used almost anywhere where analytics, R&D and production takes place. The core products are lab reagents, solvents, and specialty products supporting the entire drug development cycle - from research to production. Two well-known brands are Calbiochem® and Novagen®. The focus of the San Diego Bioscience Division will be Cellular Analysis, Molecular Biology, Recombinant Protein Expression, and Cloning and Expression. EMD is a wholly owned subsidiary of Merck KGaA - a global pharmaceutical company. This division offers the stability of a large pharma company, with an entrepreneurial and innovative culture of a smaller division. Drug discovery and screening: Innovative reagents for combinatorial chemistry, peptide synthesis, protein expression, immuno assays and many other key analytic reagents and solvents. Drug development to manufacturing: Chromatography media and production enzymes for conventional synthetic and biotechnology recovery process operations. The high-performance brands of products are widely-used in downstream bioprocessing and are supported by worldwide accepted, comprehensive regulatory support files. The company is a responsive and reliable partner for custom synthesis of active pharmaceutical ingredients. The cGMP production facilities for custom synthesis and services are equivalent to the facilities used for in-house pharmaceutical production. Business growth will be driven by increased market penetration of existing product lines and introduction of innovative new products via internal development and an active technology acquisition program. See website: www.merck-chemicals.com/life-science-research
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April 20, 2009 San Diego, CA AD: 736 |
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Title: Qualit
y Manager
This individual has the primary responsibility for managing the quality assurance function, which includes the internal audit system, third party audits (e.g., FDA, Notified Bodies), the training management system (e.g., through Master Control Software and development and implementation of ISO/QSR training), risk management program, and managing the document control system and the QA department employees. This individual actively supports corporate strategic goals and objectives through oversight of the various Quality Assurance systems. Work cross-functionally with a wide range of employees from senior management to entry level. Persuade peers and management on the attitudes and practices of quality throughout the organization to develop an environment of continual improvement by facilitating change throughout the organization and affecting every aspect of the company's products, processes and services.
Education and Experience: " BS/BA or equivalent work experience. " Preferred minimum of 5-7 years progressively responsible experience in quality system management in medical device and high volume manufacturing environments. " Auditing experience is a must and certification is strongly preferred. " Knowledge and work experience with Document Control Systems required. " Previous supervisory experience required. Knowledge/Skills: " Strong knowledge of quality systems in a medical device manufacturing environment (ISO, CMDR, QSR, IVDD, and other worldwide regulations as appropriate). " Ability to work cohesively with multi-disciplinary working groups. " Excellent written and verbal interpersonal skills to influence many diverse internal and external customer groups. " Ability to influence and work with personnel at all levels. " Managerial Skills - Employee & Team Development / Career Development " Computer skills - proficient in Microsoft Office, operating systems, voice and email, etc. " Project management, multiple tasking and excellent prioritization skills.
Founded in 1979, Quidel Corporation is a worldwide leader in developing, manufacturing and marketing rapid diagnostic solutions at the point-of-care in infectious diseases and reproductive health. We focus primarily on the physician office lab (POL) and acute care markets globally. Quidel also develops research products, through its Specialty Products Group (SPG), in oncology and bone health with future point-of-care applications. Quidel is a publicly traded company with manufacturing operations in San Diego and Santa Clara, California. We offer exceptional benefits that start at the date of hire, a competitive compensation package, outstanding recognition and rewards and a terrific work environment. Our people make the difference! How to Apply: Please visit our website at www.quidel.com and click on link to Careers. Located at 10165 McKellar Court San Diego, CA 92121 (Map)
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