Product Integrity Manager

4 days ago


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

This Quality Engineer position offers a unique opportunity to work with a leading medical device manufacturer in the Milwaukee area. As a key member of the Quality team, you will be responsible for supporting regulatory inspections, auditing, and investigating product design and manufacturing quality.

Responsibilities
  • Supports regulatory inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
  • Leverages project management skills to lead various product and process improvement methodologies.
  • Reviews changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Leads risk analysis and develops protocols and reports for test method validations.
Requirements
  • Bachelor's Degree in Engineering-related field; Master's Degree preferred.
  • 4+ years of experience in a manufacturing environment, specifically in metal working or machining.
  • Project Management and Lean Manufacturing experience.
  • Excellent communication and interpersonal skills.
Compensation
  • A competitive base salary: $89,000 per annum.
  • Bonus opportunity up to 5%.
  • Comprehensive benefits package including Medical, Dental, and Vision.
  • 15 PTO Days + 10 holidays.
  • 401(k) with 3% company match.

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