Sr. Quality Engineer

We anticipate the application window for this opening will close on - 7 Jan 2025 Position Description: Sr. Quality Engineer for Medtronic, Inc located in Santa Ana, CA. Develop, modify, apply and maintain quality standards and protocols for processing materials into subassemblies or finished device, develop and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production/testing equipment; conduct quality assurance tests; and perform statistical analysis to assess the reliability and capability of processes and products. Leverage Quality Engineering for medical device components meeting specifications. Navigate government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), State of the Art (SOTA) and Good Manufacturing Practices (GMP). Coordinate Risk Assessments including Preliminary Hazard Analysis (PHA), Process Failure Mode Effect Analysis (PFMEA) and ISO 14971 Risk Mgmt. for Medical Devices. Coordinate Non-Conformances, Complaints and Corrective and Preventive Actions (CAPA). Leverage Process Improvement Tools including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis, 5Whys, Fishbone and cause mapping. Leverage Design of Experiments (DOE) methods to establish process development. Develop of V&V (verification and validation), IQ, OQ, and PQ. Leverage knowledge of and work with animal tissue processing including porcine and bovine. Relocation Assistance is not available for this position. Basic Qualifications: Bachelors’ Degree or foreign equivalent in Mechanical, Industrial, Biomedical Engineering, Nanoengineering, or related engineering field and four (4) years of experience as a quality or manufacturing engineer for medical devices. Or alternatively, Masters’ Degree or foreign equivalent in Mechanical, Industrial, or Biomedical Engineering, Nanoengineering or related engineering field and two (2) years of experience as a quality or manufacturing engineer for medical devices. Must possess at least two (2) years’ experience with each of the following: 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP; PHA, PFMEA, and ISO 14971; Non-Conformances and CAPA; DMAIC, Root Cause Analysis, 5Whys, Fishbone, and cause mapping; DOE and process development; Development of V&V & IQ/ OQ/ PQ; Animal tissue processing including porcine and bovine. Salary:

$108,500 to $141,600 per year

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