Senior Quality Assurance Specialist

4 weeks ago


Saint Charles, Missouri, United States Michael Page Full time
Job Summary

We are seeking a highly skilled Quality Assurance Engineer to join our team at Michael Page. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and integrity of our medical device products.

Key Responsibilities:

  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
  • Lead and implement product and process improvement methodologies.
  • Review the adequacy and correctness of changes to Bill of Materials, Assembly Procedures, Drawings, Component Specification, 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.
  • Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

Requirements:

  • Relevant Quality Assurance Engineering Experience
  • Bachelor's Degree (Science Related)
  • 3+ years of experience in a Cleanroom environment
  • Strong Medical Device Manufacturing Experience
  • Good knowledge of statistical tools and appropriate use of Design of Experiments (DOE) when developing recommendations
  • Excellent communication and interpersonal skills
  • Working knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR and cGMPs

What We Offer:

  • Competitive base salary between $80,000-$95,000, depending on experience and skills
  • Bonus opportunity up to 5%
  • Comprehensive benefits package including Medical, Dental and Vision
  • Life and AD&D Coverage
  • Short-term disability coverage
  • 15 PTO Days + 10 holidays
  • 401(k) with 6% company match


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