Quality Assurance Engineer for Medical Equipment

3 days ago


Milwaukee, Wisconsin, United States Michael Page Full time
About the Role

The Quality Assurance Engineer will play a critical role in ensuring the quality of medical devices manufactured by our clients. This is an exciting opportunity for a motivated individual to join our team and contribute to the development of innovative products.

Key Responsibilities:
  • Support regulatory agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Implement various product and process improvement methodologies.
  • Review the adequacy and correctness of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc.
  • Lead in the completion and maintenance of risk analysis.
  • Develop various inspection techniques and procedures to ensure product integrity to design specifications.
Benefits:
  • Competitive base salary between $80,000-$90,000, depending on experience and skills.
  • Bonus opportunity up to 5%.
  • Comprehensive benefits package including Medical, Dental, and Vision.
  • 15 PTO Days + 10 holidays.
  • 401(k) with 3% company match.
Requirements:
  • Bachelor's Degree in Engineering or a related field.
  • 4+ years of experience in a manufacturing environment, specifically in metal working or machining.
  • Project Management and Lean Manufacturing experience.
  • Good knowledge of statistical tools and Design of Experiments (DOE).
  • Excellent communication and interpersonal skills.
  • Working knowledge of ISO 9001:2015, ISO 13485:2015, 21 CFR, and cGMPs.


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