QUALITY ASSURANCE ENGINEER Job Listing at Professional Recruiter Associates in San Diego, CA (Job ID 6385)
Quality Assurance Engineer
The QA Engineer is responsible for providing Quality Assurance input and guidance for Manufacturing, Supply Chain Quality, and R&D activities. The QA Engineer will also be responsible for supporting quality assurance and regulatory issues to assure compliance with FDA regulations, corporate directives, ISO 13485 standards and Company strategies.
Job Responsibilities include, but are not limited to:
1. Active participation in defining activities to assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, CMDR, ISO 13485 and the MDD).
2. Takes a leadership role in the development of quality and operating procedures to assure alignment with current GMP/QSR, ISO and MDD requirements.
3. Participates in New Product Development and will be responsible for the development of quality plans, verification of engineering tests and measurement practices for new and existing products using QA Tools (TQM, FME, DOE, SPC, and Risk analysis)
4. Analyzes problems occurring in the processing, fabricating, assembling and testing of products and develops changes and corrections to prevent reoccurrence.
5. Develops inspection and testing methods and participates in the preparation of quality assurance specifications and procedures to implement such methods.
6. Takes a leadership role in assuring all activities in the area of equipment, process and software validations meet FDA and International regulatory requirements.
7. Active participation in the review of engineering specifications to assure that adequate quality assurance requirements are met and designs are adequately transferred into manufacturing with high process capability measured against Critical to Quality Design Output Requirements.
8. Administers supplier audits, surveys and initiation of corrective action plans.
9. Will Chair the Material Review Board (MRB)
10. Supports annual training to the requirements of QSR, CMDR, ISO 13485 and the MDD for all appropriate personnel as necessary.
11. Participates in CAPA meetings to ensure adherence to requirements and closure of CAPAs
12. Oversees and manages incoming Supplier Quality; initiate and drive Supplier Corrective Actions.
13. Facilitates Design and Process FMEA’s and oversees mitigation efforts to closure; participates in design reviews to ensure adherence to design control requirements.
• Must have a bachelor’s degree in engineering (EE preferred) or a related field and/or a combination of practical and educational experience in the medical device industry.
• ASQ CQE required after attainment of position if not already held.
• 3+ years experience in engineering is expected with the application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device) regulations a plus. Focus on Design control/transfer, process validations, product development supports is a must.
• Lean Six Sigma Green Belt or higher is a plus. Experience with alternative Quality related tools (D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM) is also a plus.
• Solid background in electrical products using software/firmware, troubleshooting, design transfer and burn-in testing.
• Ability to understand and interpret electrical and mechanical drawings and data - electronic schematic diagrams, wiring diagrams, mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs.
• Working knowledge of US, Canadian and International safety standards for medical devices.
• Proven project management skills, with the ability to complete technical projects with minimal supervision.
• Proficiency in Microsoft Word, Excel and Outlook, Visio, Power Point Visual Basic, Access, and Mini-Tab or other comparable statistical analysis software application.
• Ability to write reports, business correspondence, and procedure manuals.
• Strong organizational, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
• Must be able to work in a team environment.
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