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JOB TITLE: Software Validation EngineerDEPARTMENT: Engineering REPORTS TO: VP of Engineering QUALITY
DESCRIPTION This position is responsible for the design validation activities associated with software related product(s)/system(s) in accordance with the company's Quality System, FDA, international regulatory and customer requirements. This position will ensure that assigned product(s) are designed and tested to facilitate manufacturability and will be responsible for technology transfer to manufacturing. Provide technical assistance to other members of the project team. Works with considerable independence to ensure new and/or revised software and equipment are validated in accordance with regulatory standards.
DUTIES/RESPONSIBILITIES: 1. Software Testing: Establish functional requirements, deliverables, time lines, budgets and develop corporate status reports of projects/products. May work with or supervise project team in developing detail specifications, construction of prototypes, pre-clinical trials for new products or current product enhancements. Will be required to prepare and deliver status reports. Will develop, set up and run product testing and protocols in accordance with project plans. Will recommend and/or select vendor and material choices for product. Ensure that product documentation is in accordance with Quality System requirements. Must be fully proficient in validation processes in a GMP environment. Duties also include: " Assist in creation and maintenance of Software Specifications. " Chair software risk hazard analyses. " Define software validation requirements. " Generate appropriate test plans and reports for software verification and validation work as necessary. " Tracking System Verification test results " Provide for evolution of requirements, stress test coverage and maintain verification trace matrices. " Software unit/integration testing, white box testing, code inspections. 2. Product Enhancements: Act independently or in a team to test and validate new products and current product enhancements. 3. Manufacturability: Ensures new software or software enhancements are made in a cost effective and timely manner and with an understanding of how the product will be manufactured and used. May be required to lead or contribute to the process of transferring product from development to manufacturing. 4. Regulatory Acceptance: Provide engineering testing and documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies. 5. Intellectual Property: May work with senior staff and/or attorneys in writing and researching patents. Participates in and contributes to brainstorming sessions to generate new intellectual property. 6. Safety: Performs job functions in a safe and effective manner. Ensures that employees under their supervision are adhering to the safety procedures of the company. 7. Other duties as assigned POSITION
REQUIREMENTS: " Must be detail oriented, well organized and able to work independently and in teams. " Must have excellent interpersonal, verbal and written skills. " Must have experience interfacing with domestic and international regulatory agencies, " Knowledge of current FDA regulatory and ISO requirements and trends effecting medical devices. " Must have strong communications and project management abilities. EDUCATION: BS degree in Computer Science, Computer Engineering, or other appropriate engineering science field and a minimum of 5 years experience in systems and software verification and validation activities on medical devices. EXPERIENCE AND TRAINING: " Proven experience (5 plus years) in the medical device field " Experience with ISO13485 and FDA QSR is desired. " Thorough knowledge of software standards, quality processes, and a good understanding of embedded software development systems for device control. SPECIAL KNOWLEDGE, SKILLS AND ABILITIES: " Knowledge of software development using C/C++, C#, VHDL knowledge desired " Knowledge of electronic and software medical device compliance requirements is required Knowledge of ISO 60601 regulations is highly desirable
RESPOND TO: Patricia Bladh > > HR Specialist > > 10911 Technology Place > > San Diego, CA 92127 > > 858-217-0300 pbladh@minnowmedical.com
JOB TITLE: Quality Control Analyst
Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development organization supporting the pharmaceutical and biotechnology industries. Pharmatek focuses on bringing client compounds from discovery to the clinic with services that include compound selection, analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. We prize quality science and the people that provide it. With that, we have built a company that focuses on our clients and their success, which has in turn led to our own impressive growth and success. We are currently seeking a Quality Control Analyst to join our expanding Quality Services team at our new Miramar Facility. The QC Analyst is responsible for conducting GMP release and stability testing, method transfers and qualifications, and data analysis to support and advance the development of drug candidates. Candidates should have a BS/BA degree in Life Science and at least 3 years of experience in pharmaceutics including reverse phased HPLC, dissolution and wet chemistry. Current analytical methodology experience and knowledge in GLP and GMP regulations required. The QC Analyst must have excellent laboratory protocol, strong attention to detail, strong organization skills and outstanding oral and written communication skills. Pharmatek offers a dynamic culture with outstanding employee benefits including an on-site fitness facility, matching 401k plan, profit sharing and stock options. We encourage and support individuals in the achievement of personal and professional goals and insist on excellence in everything we do. To be a part of this, please send your resume to: http://www.pharmatek.com/careers.html www.pharmatek.com
JOB TITLE: Quality Control Supervisor Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development organization supporting the pharmaceutical and biotechnology industries. Pharmatek focuses on bringing client compounds from discovery to the clinic with services that include compound selection, analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. San Diego Miramar facility.
The QC Supervisor is responsible for GMP release and stability testing, method transfers and qualifications and data analysis. Candidates should have a BS/BA degree in Life Science a minimum of 5 years of experience in a pharmaceutics environment including reverse phased HPLC, dissolution and wet chemistry. The QC Supervisor must have at least 3 years' GMP experience in Quality Control and one year of supervisory experience. Strong oral and written communication skills, excellent laboratory protocol including attention to detail required. Pharmatek offers a dynamic culture with outstanding employee benefits including an on-site fitness facility, matching 401k plan, profit sharing and stock options. We encourage and support individuals in the achievement of personal and professional goals and insist on excellence in everything we do. To be a part of this, please send your resume to: http://www.pharmatek.com/careers.html www.pharmatek.com
JOB TITLE: Sr Quality Engineer Precision Engine Controls has an immediate opening for a Sr. Quality Engineer. This position will report to the Quality Manager. They are responsible for defining/providing statistical data on key electronic/mechanical parts and processes. Determines/quantified trend information on internal processes to improve / reduce quality / manufacturing issues on electronic/mechanical assemblies & control units. Investigate and recommend alternatives to product designs and manufacturing methods. Will be considered backup to Quality Manager. For more information contact Patty Clark at pclark@precisioneng.com
JOB TITLE: Senior QA Associate
All candidates can apply at www.synteract.com or contact Micaela Meeks Human Resources Representative P 760.476.8879 F 760.929.1421
JOB DESCRIPTION " As the Senior Quality Assurance Associate, you will ensure compliance with applicable GCP regulatory requirements including assisting with the setting of QA targets, the development of QA guidelines, the management of standard operating procedures (SOPs), and ensuring SOP training and utilization. You will also prepare for, and participate in client, internal, and/or vendor audits. Additional tasks will include creating and maintaining QA Audits Plans for internal audits, performing internal audits and assisting in the development of the departmental response, preparing for and participating in client audits, potential corporate partners, or regulatory agencies, and contributing to audit responses. May perform other duties as assigned.
JOB SKILLS Qualified candidates will possess a bachelor's degree or equivalent in a related field of study and 5-8 years related experience. JOB EXPERIENCE Requires intermediate proficiency in both Microsoft Word and Microsoft Excel and the ability to use Access or similar database software. Must possess a professional demeanor, a customer service demeanor; demonstrate organizational skills, keen attention to detail and an emphasis on quality; takes initiative, is self-directed, and able to multi-task.
JOB TITLE: 3 Quality Positions for GE Located in Salt Lake City, UT.
Contact: Allyson Klasinski GE Healthcare Talent Acquisition Recruiter T 414.815.1722 F 414.815.1054 allyson.klasinski@ge.com Apply at www.gehealthcare.com/careers
Design Quality Engineer Quality Assurance Director Internal Auditor
JOB TITLE: Quality Engineer Description: This position is for an experienced quality engineer who will drive supplier quality programs and improve manufacturing. This individual will be responsible for internal quality including, RMA , MRB, vendor audits and vendor qualification processes. The candidate must have a hands-on style with an eye for detail. Will also be company's point of contact for regulatory testing and UL site audits. Will be responsible for implementation of ISO or TL processes through certification. Job Requirements: Design Control: Able to define document requirements for product, process and test method verifications and validations. Work with company's design team(s) writing specification, Incoming Receiving Inspection reports to ensure regulatory compliance. Technical: Understanding of process, design and product/design verification/validation. Able to relate information to specifications, product claims and design. Demonstrates project management skills. Understands the impact of testing and process variation on manufacturability and field performance. Proficient at risk management.
MINIMUM REQUIREMENTS: (Necessary basic knowledge, skills, abilities and education) o 5 years experience with moderate volume manufacturing o Ability to use analytical tools and methods for problem solving o Experience with In Circuit Testing is required o BS in engineering or related field is required. DESIRABLE REQUIREMENTS: (Preferred requirements that are in addition to minimum requirements) o Strong knowledge of geometric dimensioning and electrical schematics is high desirable o Knowledge of RoHS (Restrictive use of Hazardous Substances) and WEEE (Waste Electrical & Electronic Equipment Device) requirements and implementation is a plus o Experience with semi conductor processing is a plus o Background in reliability testing, MTBF (Mean Time between Failures) If you have any questions, please contact customer_service@linkedin.com . (c) 2008, LinkedIn Corporation -- Gratefully, Ron Lohrbach 10914 New Salem Circle San Diego, CA 92126 email: rlohrbach@gmail.com
JOB TITLE: Quality Assurance Associate Job Code #08-058 This position will administer the document change management and document control systems; ensuring timely issue resolution, follow up, tracking, notification of change and closure of documents generated. Specific duties include: " Maintaining electronic and controlled hard copy files. " Administering employee GXP training program, maintaining associated documentation in compliance with SOPs. " Assisting in the identification and scheduling of applicable training courses. " Identifying procedural compliance risks in the Change Management and Training Systems and proposing corrective actions. " Assisting in the development and revision of SOPs, forms and related controlled documents. Qualified candidates will possess: " BA and 1 - 2 years related experience " Proficiency with Microsoft Office, Adobe, and internet browsers " Working knowledge of government and industry quality assurance codes and standards. " Knowledge of scientific terminology is a plus. Metabasis Therapeutics, Inc. is a San Diego-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to address some of the world's most widespread and costly chronic diseases. Metabasis has a broad product pipeline targeting large markets with significant unmet medical needs. We are specifically focused on metabolic diseases involving pathways to the liver, such as diabetes and hyperlipidemia, as well as liver diseases such as hepatitis and liver cancer. We currently have five internally discovered product candidates in clinical development as well as an active discovery team seeking additional product candidates to treat metabolic diseases. Metabasis Therapeutics is an equal opportunity employer offering a competitive compensation package including a stock option program & comprehensive benefits, in a fast-paced, highly stimulating, team-oriented environment. Qualified applicants are invited to submit a resume and cover letter to: Metabasis Therapeutics, Inc. Human Resources Dept. 11119 North Torrey Pines Road La Jolla, CA 92037 Fax: (858) 458-3504 jobs@mbasis.com www.mbasis.com
JOB TITLE: Vice President of Quality and Regulatory AffairsContact: Laura Bowden Associate Partner lbowden@lucasgroup.com Lucas Group P: 800-282-0360 x143 D: 858-652-3943 F: 858-558-0704 www.lucasgroup.com
Medical Technology Company who is a market leader in clinical data management for hospitals and commercial laboratories and is headquartered in Tucson, AZ. It is a newly created position that reports directly to the CEO. Salary is approx $160-180K (which is appropriate for Arizona) and a 25% target bonus. A Software Quality background in an FDA Regulated environment is key.
JOB TITLE: Program QA ManagerFull Time, Regular Posted 7/30/2008 Job Category MIS - Info Tech / Telecommunications Req ID 124223 Location San Diego, CA % Travel 10 Recruiter contact: Sheri Toler Sr. Technical Recruiter Health Solutions Business Unit M, T, W, F - Office: 703-375-2406 Th - Cell: 703-225-8646 Fax: 703-375-2567 tolers@saic.com ADP II Security clearance is required. Requires US Citizenship.
JOB DESCRIPTION: Perform and manage the QA functions in support of multiple DoD Military Health Systems (MHS) Programs and other Federal Government contracts. Management activities will include, but will not be limited to: planning, developing schedules, allocating resources, budgeting, reviewing work products, conducting process evaluations, and mentoring on QA responsibilities in support of a wide-range of Federal Government programs. Technical responsibilities will include, but will not be limited to: investigation of the current processes and recommending process improvement; developing, documenting, and implementing processes/procedures; conducting ongoing program process evaluations, reviewing project products, generating process audits and review reports; monitoring requirements related to performance-based services acquisitions; and providing program interface with the development teams. This position will require interacting with program managers, product managers, technical leads, and customers. The duties associated with this position will involve working on complex problems where analysis of situation or data requires an evaluation of tangible and intangible variables. The candidate will exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining establishing and maintaining quality and process standards.
REQUIRED EDUCATION/SKILLS: Minimum of a BS in Computer Science, Information Systems, Engineering, or related technical field with at least 8+ years as a software developer, system engineer inclusive of at least 5 years of dedicated QA is required. Additionally, the successful candidate should have at least 8 years of experience in implementing QA programs and performing the full range of QA functions as specified by customer and project requirements. The candidate must have good interpersonal skills, a cooperative attitude, and the ability to work well with all levels of staff and management. The candidate must have experience in supporting proposal teams. The candidate must be able to write clear and understandable plans and procedures. The candidate must be a US citizen and capable of attaining an ADP II Security Clearance. DESIRED SKILLS: Practical experience in the System and Software Lifecycle Development process is strongly desired. Basic office applications (word processing, spreadsheets, graphics, database, and e-mail) and experience in automating the QA activities. Work experience with SEI CMMI Level 3 PPQA requirements is desirable. Background in software and system testing process is a plus.
JOB TITLE: Quality Control ManagerIQinVision Summary IQinVision is the world's leading manufacturer of Megapixel Network Cameras
Responsibilities The Quality Control Manager will lead the quality assurance effort for IQinVision to move from current high resolution digital camera configuration to a new higher end optical camera state of technology to meet demanding customer requirements and deliver operating profit to the corporation. Working with a team of highly skilled engineers and operations management personnel, this position will guide our company and contract partners to the "best practice" manufacturing methods.
Experience Applicants should have: "Minimum 5 - 7 years Quality Assurance / Quality Control position(s), preferably in high growth environments and within both small and large original equipment manufacturing companies (OEM). "Formal higher education, preferable Bachelor's degree or graduate education in sciences, engineering, or business. "Experience with electronic equipment manufacturing and materials, offshore suppliers, and customers requiring high technology products. "Practical knowledge of optics and optical manufacturing techniques, preferred. "Experience with high technology product life cycles. "Technical knowledge base of ISO9001 certification guidelines in a manufacturing environment. "Statistical process control systems and Cpk measurement techniques. "Incoming quality control methods and equipment use. "Change Control Board and Material Review Board participation. "Understanding/interpretation of complicated electronic-mechanical specifications. "Experience with IPC-A-610D and ANSI workmanship guidelines. "Extensive manufacturing knowledge of metal stampings, die casted parts, electronic components, plastic injection molded parts, cable assemblies, semiconductors, box built chassis, turnkey finished goods and tooling from Asian suppliers. "Knowledge of high technology product life cycles and end-of-life material planning. "Comprehension of master scheduling, production planning, inventory control, material requirements planning, contract administration in purchasing, and third party logistics (3PL's). Performance Skills "Business Systems: Knowledge of Microsoft Office Suite software, formal MRP systems, computer aide design, and document control software (preferably Agile). "Organization and Planning: Must be able to act independently and with the least amount of direct supervision, self-organize, schedule, and prioritize workload and manage simultaneous activities under stringent time constraints. "Teamwork: Able to work with concurrently with all levels of IQ staff and outside parties in such a manner as to achieve company goals and objectives; past leadership and team management skills. "Decisiveness: Results oriented person that is able to make decisions on available information, take action, make business commitments, and react with work-related emergencies as needed. "Relationship Building/Cultivation: Able to build and continually cultivate relationships with key suppliers and customers; must understand and work effectively within cultural norms of offshore supply chain partners. Business travel may be required. "Special Vision Requirements: Close vision capability at 20 inches or less. Color vision recognition and perception with ability to identify and distinguish colors. Focus ability to adjust the eye to bring an object into sharp focus. Reading, computer screen, and microscope vision.
Contact Information for Resumes: maureenkube@roadrunner.com
JOB TITLE: Quality Engineer - Position filled 9/24/08
JOB TITLE: QA Inspector for First Article Inspections (FAI) NOTICE:
JOB POSITION FILLED With an applicant that responded from the ASQ website! EXLNT!
JOB TITLE: SR. QUALITY ENGINEER Company: Global healthcare products company with leading brands. Apply to: Please send resumes to innesfreeil@yahoo.com
SUMMARY: Provide quality engineering support in design and development of medical device products, primarily ventilators and ventilation accessories, and facilitate the application of design controls. Translate Quality Standards into processes and procedures, and apply these to the new product design process. FUNCTIONS: 1. Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product requirements. 2. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation. 3. Ensure successful transfer of new products to production facility. Review production processes for quality of validation. 4. Review and approve verification and validation test plans. Ensure verification / validation results demonstrate compliance to medical device standards. 5. Provide training to project teams on verification/validation, statistical methods and design controls. 6. Lead product risk assessment efforts within product teams. 7. Review Design History Files and Technical Files for conformance to applicable requirements. 8. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues. 9. Conduct internal quality system and supplier quality audits.
REQUIREMENTS: " Bachelor of Science degree in an engineering discipline, EE preferred " Skilled in test plan development and root cause failure analysis " Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments " Good verbal (including presentation) and written communication skills, especially technical report writing " Ability to effectively work on project teams " Familiar with reliability analysis and test methods " Familiar with ISO 14971, or strong experience in risk evaluation techniques, such as FMEA and/or fault tree analysis " CQE certification - desired
JOB TITLE: Supv, QRA Mgmt Company: Cardinal Health Respond to: Patrick Monteforte (858) 617-2272 (wk); 858-617-2478 (fx) patrick.monteforte@cardinalhealth.com
Responsibilities: Coordinates and supervises the daily activities of business support, technical or production staff in an assigned area " Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors " Has in-depth knowledge of work processes and tools within own area " Applies expertise to solve standard and non-standard problems within own area " Makes decisions, often difficult and/or unpopular, by carefully weighing pros and cons and acting for the benefit of the work team; coaches/supports subordinates in their decision-making efforts " Role models Cardinal Health's high ethical standards and code of conduct " Provides direction in discussing and creating development plans " Provides input into succession planning process for own work area " Aligns individual goals for self and others with work area/functional goals " Builds confidence and respect of others through a positive and energizing style " Assists work team in the achievement of goals/ commitments; achieves own goals/commitments regardless of obstacles " Works within budgetary/ financial objectives set by manager, applying knowledge of profit drivers to work processes within own area " Is aware of internal/external business issues " Identifies specific opportunities for long-term change within own work team or product/service " Builds customer relationships, interprets customer needs and assesses their business requirements " Leverages customer knowledge to develop alternative solutions and shares key learnings with others " Resolves day-to-day or routine problems using defined processes " Works/brainstorms with work team and provides suggestions for solutions that contain the appropriate level of risk; ensures work team understands and supports the focus on operational excellence " Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team members, regardless of background; mentors and empowers others to achieve success " Effectively listens to and explains difficult issues to reach shared understanding and build alignment Accountabilities in this role
Qualifications " BA in Business or related preferred " 0 -3 years customer care/service " 2-3 years direct supervisory exp " knowledge of quality, regulatory affairs, FDA regulations "
JOB TITLE: Consultant, Customer Advocacy-TechnicalCompany: Cardinal Health Responsibilities: Demonstrates experience supporting the technical assessment of issues reported by the customer " Respond to: Patrick Monteforte (858) 617-2272 (wk); 858-617-2478 (fx) patrick.monteforte@cardinalhealth.com
Demonstrates advanced knowledge of the product line and how products are used and serviced " Develops and documents test plans for many issues " Consults with others when advanced expertise is required to properly analyze an issue " Makes an assessment of the complaint classifications, based on technical knowledge and formal flow charts " Trains others to follow the written procedures and flow charts " Clearly communicates the regulatory requirements " Documents customer feedback and initial assessment information without adding opinion " Communicates with both the customer and business owners to achieve the required outcome to ensure proper resolution for most issues handled " Escalates to others when issue is beyond their scope of experience or knowledge " Writes technical closure letters to support customer issues that are sensitive due to the nature of the issue or the customer's expectations. 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 " Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and " 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. " 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. " Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity
Qualifications " BA degree " Advanced degree preferred " 4 -6 years applied experience " Knowledge of FDA regulations, Quality Control and Documentation
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