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Sr. Quality Engineer
| Company | Medtronic |
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| Location | Menlo Park, CA, USA |
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| Salary | $125000 – $158400 |
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| Type | Full-Time |
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| Degrees | Master’s |
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| Experience Level | Senior |
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Requirements
- Master’s Degree in Biomedical Engineering, Biomedical Sciences, Mechanical Engineering, or Industrial Engineering or related discipline
- Two (2) years of experience as a Quality Engineer or related occupation in medical device industry
- At least two (2) years’ experience with 21 CFR Part 820 QSR, ISO 13485, EU MDR, SOTA, and GMP
- At least two (2) years’ experience with Risk Assessments, PHA, and PFMEA
- At least two (2) years’ experience with NCMR & CAPA
- At least two (2) years’ experience with DMAIC, Root Cause Analysis, 5Whys, Fishbone, and cause mapping
- At least two (2) years’ experience with DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV
- At least two (2) years’ experience with V&V and IQ/OQ/PQ
Responsibilities
- Support manufacturing operations and evaluate compliance of materials and processes with specifications and customer requirements
- Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished materials product
- Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
- Support Internal and External audit preparation and activity
- Navigate government and industry regulations including 21 CFR Part 820 QSR, ISO 13485, EU MDR, SOTA, and GMP
- Coordinate Risk Assessments, Preliminary Hazard Analysis (PHA) and Process Failure Mode Effect Analysis (PFMEA)
- Participate in preparing, critically reviewing, and approving Non Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs) Investigations, Complaints and validation activities
- Leverage Process Improvement Tools to support operations including DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping
- Leverage Design of Experiments (DOE) methods to establish process development and Statistical analysis tools for process capability
- Develop V&V (verification and validation) using Installation Qualification, Operational Qualification, and Process Qualification (IQ/OQ/PQ)
Preferred Qualifications
No preferred qualifications provided.
