Senior QA Engineer in Medical Device Manufacturing

7 days ago


Saint Charles, Missouri, United States Michael Page Full time
Job Description
  • Support Regulatory and Agency Inspections: You will support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality control and assessment.
  • Lead Product and Process Improvement Initiatives: Leads and implements various methodologies for product and process improvement, including reviews of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, and more.
Requirements
  • Relevant Experience: Relevant experience in Quality Assurance Engineering and a Bachelor's Degree in a Science-related field are required.
  • Background in Medical Device Manufacturing: A strong background in medical device manufacturing, including familiarity with FDA regulations, EU MDR, ISO 13485:2015, 21 CFR, and cGMPs.
Benefits
  • Competitive Salary and Bonus Potential: Enjoy a competitive base salary ranging from $80,000 to $95,000 and a bonus potential of up to 5%.
  • Comprehensive Benefits Package: Receive a comprehensive benefits package that includes medical, dental, and vision coverage, life insurance, short-term disability coverage, 15 days of paid time off (PTO) plus 10 holidays, and a 401(k) plan with a 6% company match.


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