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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.

January 29, 2009 San Diego, CA AD: 824

Job Title: Quality Engineer

QA 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. " Be fluent in English (written and spoken) Success Factors 1. Represent Quality Assurance to New Product Development " Participate in planning sessions for programs assigned " Work with engineering and customer to define quality requirements " Take the lead in working with other Quality Assurance staff including Quality Manager, Associate Quality Engineer and Inspectors to ensure quality requirements can be met 2. Support the Quality Management System " Lead a minimum of three internal audits to AS9100 requirements over a 12 month period " Participate in MRB (Material Review Board) meetings at least once per quarter " Review, revise or create a minimum of six procedures (QPs, SOPs, etc.) or as assigned each 12 month period " Prepare and present at least one training event each quarter of the calendar year 3. Represent Quality Assurance to Production " Work with production to investigate and recommend alternatives to manufacturing methods as required " Work directly with customers to resolve quality issues " Conduct product line review activities and report results to the appropriate personnel (Quality Manager, Supervisor, etc.) upon identification of a discrepancy to the established process " Assist production in investigating the cause and corrective action if three or more of the same type of part shows up sequentially in the NCR Log with the same type of nonconformance " Assist in preparing monthly metrics such as scrap rate, nonconformance patterns, and on-time delivery

Apply directly at http://www.composites.sparta.com/index.php

January 29, 2009 San Diego, CA AD: 823

Job Title: Senior Quality Engineer

San Diego, CA Description: Be part of an exciting Class III medical device company manufacturing spinal surgery products. Responsibilities: " Develop, implement, and improve overall quality systems and reliability of products " Qualify equipment required to perform inspection - design and/or procurement " Validation, testing, inspection, and sampling " Transfer of design to contract manufacturer " Qualification and validation requirements " Interface directly with suppliers " Support Non-Conforming Material Program " Help analyze CAPA Program and resolve product quality issues " Identify and trend quality issues " Train employees and document Education/Experience " BS/BA in an engineering or technical discipline " 5 years experience in a regulated environment required " Supplier Management experience required " Strong Design Control experience required " Packaging or validations experience required " QSR, ISO 13485, and the MDD experience required " American Society for Quality Certified Engineer (CQE) preferred Please contact: Lewie Casey Med Exec International Phone: 818-552-4173 Email: lcasey@medexecintl.com Web: http://www.medexecintl.com

January 28, 2009 San Diego, CA AD: 822

Job Title: Configuration Coordinator

Reviews and approves the initial documentation and its changes of all deliverable material within the organization. Responsibilities: Maintains a Configuration Management Matrix with the following inputs: " Purchase Order requirements " Sub Assemblies & revisions " Details & revisions " Specifications and revisions " Quality Notes " Test procedures " Work instructions Leads Configuration Control Board Meetings (CCB) " Identify participants of the CCB and organize the meeting " Review & verify all document revisions (Inputs) in preparation of the meeting " Provides an outline of the processes to achieve the change " Reviews the current production schedule for the incorporation of a change window " Set the Effectivity of the change " Documents the outputs of the CCB meeting and disseminates action items to the responsible function. " Coordinates follow up meetings to ensure revision is implemented " Ensures that existing hardware is dispositioned Control of Document Revisions: " Ensure the latest revisions of documents are on distribution at point of use. " Ensure released hard copies of documents contain the document control stamp and necessary approvals for release. " Ensures obsoleted document are available to authorized personnel only and maintained per QP 4.2.3 Control of Documents. Ability, Education, Knowledge, Qualification and Skill Requirements: " BA in a technical field or 3+ years experience in Configuration Management. " 3 plus years in an Aerospace/DoD Manufacturing environment is required. " 2-5 years experience with an Electronic Document Control System (EDCS); any experience with Master Control EDCS is a plus. " Strong organizational skills are critical for the success of the CCB. " Strong communication skills. " Must possess strong leadership skills in order to guide the work of the CCB. " Must have above average experience in scheduling. " Ability to Coordinate & schedule Effectivity dates of product revisions " Familiarity with Microsoft Project (setting up and maintaining projects). " This position requires the ability to read and interpret engineering drawings (any experience with GD&T is a plus). " Must have a high proficiency with MS Office Products, specifically Excel.

Apply directly at http://www.composites.sparta.com/index.php

January 26, 2009 San Diego, CA AD: 821

Job Title: Product Complaint Coordinator

Alphatec Spine Product Complaint Coordinator - SC10173

January 19, 2009 San Diego, CA AD: 820

Job Title: Analyst (I/II), Quality Assurance

Contact: Mary Richardson, QA Director at 858-450-3123 or mary.richardson@nextpharma-us.com

Responsibilities: The Quality Analyst responsibilities are divided into three primary functional areas: Raw Materials Inspection, Label Generation, and Water Sampling / Environmental Monitoring. Raw Materials Inspection: The Analyst is responsible for inspecting in-coming raw materials, releasing raw materials, obtaining and submitting test samples to the appropriate contract laboratory, coordinating receipt of test results. Label Generation: The Analyst is responsible for ordering label and ribbon stock, generating Master Label templates from approved label specifications, producing labels for specific product lots, ensuring labels are verified as correct and are released in time to meet the manufacturing schedule. Water Sampling / Environmental Monitoring: The Analyst is responsible for ensuring all potable, Purified Water and Water for Injection samples are obtained as scheduled and submitted to the appropriate contract laboratory for testing. He or she is also responsible for obtaining occasional environmental samples in the classified cleanrooms to verify Manufacturing's sampling techniques and results. The Quality Analyst may also support Document Center by maintaining documents and document sites; assisting with investigations as directed by a QA Specialist; or other duties as assigned by the QA Director. Requirements: 1. High school diploma required, 1-2 years college coursework preferred 2. 1-2 years in a FDA or ISO regulated company is preferred

January 17, 2009 Temecula AD: 822

Job Title: Validation Engineer III
Location: Temecula, CA
Duration: 3 months
Contact: Vivek Chalana (973) 993-9383 Ext 3478 Vivek_Chalana@artechinfo.com

January 15, 2009 Nevada AD: 821

Quality Control Laboratory Technician

Level 3 in Nevada, contact Samantha at samantha@chambersresearch.com

Job Title: QE in Irvine

Quality Engineer: Automotive Products... new engagements with automotive companies and module suppliers for its semiconductor business. This is a growth area for Broadcom and we are looking to fill positions that will help us meet the automotive requirements for semiconductors.

REQUIREMENTS:Senior semiconductor Component Engineer/Supplier Quality Specialist with over 5-10 years experience in the automotive industry. BS/MS EE with 5 years + of Product or test engineering experience in the automotive semiconductor industry or have worked approving semiconductors with a module manufacturing to the automotive industry. Good written, oral presentation skills. Good interactive skills. Good computer knowledge i.e... Microsoft applications. Six-Sigma black belt a plus.

Contact: Harold Hankerson 678-525-0070 mjhh@hotmail.com

December 24, 2009 Kansas City, MO AD: 818

Job Title: QE in Kansas City ... Relocation provided

Sr. Quality Engineer with Diodes Fabtech in Kansas City/Independence-Lee's Summit, Missouri!. If you're interested, send your resume ASAP along with your desired annual salary. RELOCATION ASSISTANCE PROVIDED INTERVIEW TRAVEL REIMBURSEMENT

Contact: Harold Hankerson 678-525-0070 mjhh@hotmail.com

December 14, 2009 Vista, CA AD: 817

Job Title: Director of Operations (Carlsbad, CA)

Our Operations Director will embrace efficiency and position our company for rapid, sustained and profitable growth. You will take ownership over an entire facility with management responsibilities that will include manufacturing and inventory control along with profit & loss performance. Successful execution will require the ability to drive forward our company's adoption of our Proprietary Production System which is based on Lean Methodology, formulate and execute strategic initiatives that will increase our competitive advantage through operational efficiency and ensure that the company is always focused the right priorities by initiating and insisting upon team-centric communication. You'll lead by example and demand an environment of respect for others with the clear understanding that you are ultimately responsible for the work product and results of an entire Division and stand-alone Facility. We're a 35-year old microelectronics manufacturing company that provides complete production capability, from the initial substrate, to rigorous environmental testing, to the final "box" level assembly. We rely on a Lean approach that continues to reduce waste, allows the company ?to grow and expand services and capabilities, as well as meet the highest industry standards. Founded in 1975, we have two manufacturing locations in Southern California. This position includes Management responsibilities and full facility oversight. We've experienced consistent sales growth of more than 20% annually for the last decade and we foresee similar growth continuing into the future. Requirements: " Strong leadership skills demonstrated through championing accountability, maximizing team and individual strengths, seeking and implementing change, and aligning with critical plant and business objectives. " 5+ years experience in senior operational and strategic leadership. " Extensive, hands-on, in-depth knowledge of lean and continuous improvement methodologies. " Proven ability to drive communication throughout an organization that both anticipates and removes roadblocks. " Capable of leading and implementing the practical application of the full range of lean methods on the plant floor. " Should have implemented lean practices in at least two separate operating environments. " Solid skills in motivation and employee development; proven ability to educate and train others in new ways of doing business. " Former military background is a plus " Hands on attitude, with the willingness to be on the production floor " Talent for recognizing better and innovative ways to accomplish objectives. " Ability to effectively manage multiple projects/initiatives with budget limits and time constraints. " Effectively designed strategic plans that have led to growth of a manufacturing company " Demonstrated on-time and quality standards " Experience with international suppliers and customers " Demonstrated commitment to change management " Demonstrated leadership in process improvement " Technical aptitude in understanding complex manufacturing issues and processes. " Lean manufacturing (related) certification preferred

To apply: please send your resume and cover to our recruiting team: 52602@americanworkforce.jobs . Qualified applicants will be responded to as quickly as possible. Please note: Applicants for employment in the U.S. must possess work authorization, which does not require sponsorship for a visa now or in the future. Thanks, Kelli Ellenburg, PHR, CPRW Hire Better™ O: (512) 355-1499 ext. 104 kellie@HireBetterTeam.com Blog: http://www.Hire-Better.com Company Twitter Updates: @HireBetter & @HireBetterCEO

December 14, 2009 Vista, CA AD: 816

Job Title: Senior/Junior Quality Engineers

Enigmadiagnostics is a recognized leader in developing rapid diagnostic instruments for the detection and identification of infectious organisms at the point of care. Enigma develops portable and totally automated PCR based diagnostic instruments that provide rapid and decisive result in real time. The technology, originally developed for bio-security applications is now targeting the clinical, veterinary, defense and homeland security markets. The Senior Quality Engineer will establish, implement and maintain appropriate Quality Systems consistent with cGMP Medical Device Manufacturing requirements. This key role will assure compliance to internal and external specifications and standards.

Responsibilities: " Establish, develop and implement cGMP Quality System for Medical Device, including the policies and procedures to meet necessary requirements of the Quality System specifically US FDA's 21 CFR 820, and ISO13485. " Ensures that process requirements of 21 CFR 820, ISO 13485:2003 and ISO 9001 are met. " Create and implement corporate documents to support organization wide initiatives. " Ensures development activities follow design controls. " Coordinates product submissions to various regulatory agencies. " Design, evaluate and review work for inclusion in Medical Device Reports (MDR's) and provide leadership in the management of investigations supporting a MDR. " Actively contribute to data collection, investigation and improvements to processes to ensure that development activities follow design controls. " Participate in Regulatory strategies and compliance activities. " Communicate effectively with industry peers, regulatory agencies, customers, notified body (auditors), FDA, and Suppliers

Requirements " BS degree in Engineering or Science field. Certified ASQ Quality Engineer a plus " Minimum of 5-8 years of quality manufacturing in an IVD/Medical Device industry. 1-3 years (Jr. position) " Extensive knowledge of 21CFR820 and ISO 14385:2003 and FDA/Medical requirements including ISO14971 (risk management). " Must have effective leadership, problem solving, negotiation skills and diplomacy in dealing with team members as well as the ability to assess the impact of regulatory and quality compliance methods. " Demonstrated ability to work independently. Advanced computer skills. " Strong interpersonal and communication skills. Must be able to address questions from FDA investigators/Notified Body auditors and customer auditors by successfully communicating he company's implementation of applicable regulations and standards (especially ISO 13485 and 21 CFR 820).

Please send resume to Alda Jorgenson ajorg@roadrunner.com

December 6, 2009 Vista, CA AD: 815

Job Title: Validation Consultant

Contract in Ohio. All traveling and living expenses will be covered over the duration of the contract, slated at 5 months. SD candidates are viable.

Job Description: This person will be performing Test Method Validation as well as process equipment validation. Must have previous process equipment validation (IQ, OQ, PQ and report writing) experience at a medical device manufacturer. Strong data driven decision making skills. Strong statistics background (DOE, SPC, FMEA, and Capability Analysis). Description: Working with minimal supervision, Consultant will drive the validation of test methods and manufacturing process equipment. Write and execute protocols. Gather data and analyze the data generated during protocol execution. Write test reports including deviation reports. Define statistically valid sampling plans. Write SOPs. Provide training to employees.

Requirements: Bachelors Degree in Engineering " 3 - 5 years of Quality Engineering experience in Medical Devices " Previous experience working with injection molding and extrusion processes. " Previous medical device validation experience required. " Detail oriented with strong interpersonal and communication skills.

December 2, 2009 Vista, CA AD: 814

Job Title: Quality Engineer

JOB LOCATION: Vista, CA

CONTACT: Human resources at hr@chproducts.com Send Resume in MS Word .DOC format.

JOB DESCRIPTION: CH Products, a leading manufacturing of advanced motion controls, is searching for a Quality Engineer with primary responsibilities to provide support for new product development and established manufacturing processes for improving the performance of the overall Quality System. Specific activities for this position include: establishing quality standards, statistical methods, test methods, process control techniques, and reviewing quality system metrics to identify needed improvements. This position also supports the development of production work instructions, quality assurance specifications & inspection methods, the corrective action process, engineering change control systems & validation and verification studies aimed at ensuring product safety and manufacturing efficiency in support of ISO9000 methodologies.

Responsibilities: " ISO 9000 systems assurance. " Return Materials analysis and reviews for Corrective Action(s). " Identify and perform training needs and recommend improvements. " Develop and document assembly and test procedures for new and existing products. " Provides First Article Inspection on new materials. " Establish procedure for Statistical methods (such as Design of Experiments, Sampling and Cpk studies). " Ensure electronic assemblies are thoroughly tested to ensure a high level of quality and reliability. " Troubleshoot product and production problems and implements short and long term corrective actions. " Support production as needed to help resolve throughput issues. " Participate in quality initiatives to help improve yields and minimize failures.

Requirements: " Education: Bachelor's degree in engineering studies " A minimum of 5 years experience working in a quality systems environment " Knowledge of analog and microprocessor based electronic circuits with ability to read electronic schematics. " ISO 9001 experience in a certified facility " Must have strong electronic diagnostic skills " Working knowledge of laboratory test equipment such as oscilloscopes, multimeters and signal generators. " Leadership and interpersonal skills " Organized, responsible, self-motivated team player with good communication skills " Accustomed to functioning in a dynamic environment and enjoys hands-on projects " Proven ability to implement design improvements based on failure analysis " Familiar with ANSI Y14.5M " Competency in computer applications such as MS Word, Excel & Outlook

December 1, 2009 San Diego, CA AD: 813

Job Title: Performance Data Analyst

Kisco Senior Living operates 19 communities in 6 states and employs approximately 1400 associates. We specialize in Independent and Assisted Living and create a sense of community through our philosophy of the Art of Living WellSM.

Creates, maintains, and publishes performance and operational metrics for the entire Kisco portfolio of communities and the Home Office, including the creation and maintenance of dashboards and presentations. This position collects and analyzes a full spectrum of performance and operational metrics as well as benchmark data to identify process improvement and performance opportunities. Manages and grows the company's overall vision for metric tracking, trending and reporting while meeting management information needs according to established standards. This position works in a matrix structure, supporting Operations, the Coaching team, Home Office teams, and the communities with performance analytics. Essential Job Functions: " Retrieves, reviews, analyzes, and publishes Kisco data " Assists with the identification of root causes of performance gaps " Identifies and measures both Leading and Lagging measures of performance in a timely manner " Supports Process Coaches with analysis of data and recommendations regarding improvement of outcomes " Maintains, publishes and improves dashboards and presentations. " Maintains, analyzes and publishes the company's Scorecard and Leading Indicators, including improving the presentation and understanding of company metrics " Manages Kisco's Scorecard Accountability process with the communities " Analyzes and interprets all performance and operational metrics, performs trend analysis, and identifies future opportunities for performance improvement " Creates and executes the plan for any changes required to the infrastructure (tools, processes, templates, etc.) for all metric reporting " Responsible for creating & managing the benchmarking process for Kisco, including the identification of benchmarking sources, obtaining and sharing relevant benchmark data, and comparing to Kisco performance " Maintains a baseline of all performance targets, accurately communicates variances over time, recommends new performance metrics or process improvements in response to variances " Creates and implements performance measurement communication plans, including the use of reports, company intranet sites and company dashboards

To review the full job description and to apply, please visit our website at: http://www.kiscoseniorliving.com/careers.asp Job tracking code: 2009082

December 1, 2009 San Diego, CA or SF AD: 812

Job Title: Regulatory Affairs Specialist II

CONTACT: Kathryn Hammelman Partner PROVEN, INC. 858.412.1121 (office) 720.289.4060 (cell) 858.412.1100 (fax) www.proveninc.com

November 25, 2009 San Diego, CA AD: 811

Job Title: Manufacturing Associate - San Diego, CA

Simply Biotech specializes in recruiting exclusively for San Diego's biotech community. We are currently seeking a Manufacturing Associate for a leading and growing San Diego biotech firm. The qualified Manufacturing Associate will be a motivated biotech Professional with a desire to grow and learn. In this role, the Manufacturing Associate will be responsible for a wide range of cell-related duties including: * Cell Production/Expansion including feeding, harvesting, counting and freezing * Product seeding, growth system maintenance, labeling, packaging and freezing of final product * Final product manufacturing for commercial distribution * Culture media preparation * Retain records and write reports * Follow SOPs and perform per QSRs to ensure quality The qualified Manufacturing Associate will possess the following: * 1+ year tissue culture/cell line experience, 2-3+ years preferred * BS/BA degree preferred * Clean room experience including full gowning * Aseptic Technique experience * Experience working with SOPs in a GMP environment For immediate and confidential consideration, please email your resume to mmedley@simplybiotech.com or call 858.433.0363.

November 22, 2009 San Diego, CA AD: 810

Job Title: Software QA Engineer

Location: Carlsbad, CA

Duration: 03 Months

Duties: This is a hands-on SQA position that will be responsible for the testing and quality of the following web applications: Cold Fusion, Comergent, Day, and FAST. Work in a fast paced environment with Development, Project Management and multiple business lines. Design and develop test plans and execute tests for enterprise class web-based eCommerce applications. Tasks will include but are not limited to: QA Project Management, test planning, manual testing, test automation, test environment setup, defect logging/verification, and review of requirements and use cases. This is a 3 month contract with possible extension. Local candidates only.

Skills: Experience with enterprise class eCommerce Applications, Content Management and Search systems is preferred. Experience with authoring and maintaining acceptance test plans and test cases used for verifying software quality. Experience with enterprise class relational databases. Experience with Mercury Quick Test Pro / Load Runner / Quality Center is required. Experience with authoring and maintaining acceptance test plans and test cases used for verifying software quality. Experience with various test methods including GUI based system testing, performance testing, acceptance testing, regression testing, etc. Experience with one or more of the following technologies and applications is a plus: programming (Visual Basic, C++, ColdFusion, Java J2EE), Oracle eOne and Siebel. Strong communication skills and attention to detail are essential, as is the ability to quickly learn new applications and technologies in a fast-paced environment. Candidate should be comfortable working in Windows 98/NT/2000/XP and have a strong working knowledge of Internet browsers and Internet-related technologies.

Education: BS/BA degree in Computer Science or equivalent experience Artech is a global IT Consulting company with over 30 Fortune 500 customers.

You may visit our website at www.artechinfo.com to learn more about us. Thank you. Sincerely yours, Sourabh Pal (973) 993-9383 Ext.3316 Sourabh_Pal@artechinfo.com

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