Quality Assurance Engineer

2 days ago


Milwaukee, Wisconsin, United States Michael Page Full time

**About the Role:**

We are seeking a Quality Assurance Engineer to join our team at Michael Page. As a key member of our Quality team, you will play a critical role in ensuring the highest quality standards are met for our medical devices.

Key Responsibilities:

  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
  • Lead and implement various product and process improvement methodologies.
  • Review changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Lead risk analysis and completion of protocols and reports for test method validations.
  • Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
  • Develop inspection techniques and procedures to ensure product integrity to design specifications.
  • Evaluate and ensure disposition of non-conforming materials meet all necessary regulatory requirements.

About You:

  • Bachelor's Degree in Engineering-related field.
  • 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.
  • Working knowledge of ISO 9001:2015, ISO 13485:2015, 21 CFR and cGMPs.

What We Offer:

  • 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.


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