Quality Assurance Specialist

4 weeks ago


Saint Charles, Missouri, United States Michael Page Full time
Job Title: Quality Assurance Specialist

Contribute to the success of a global medical device product line utilized in surgeries.

About the Role:

We are seeking a Quality Assurance Specialist to join our growing Quality team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Supports regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality control and assessment.
  • Leads and implements various methodologies for product and process improvement.
  • Reviews the adequacy and accuracy of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, and more.
  • Oversees the completion and maintenance of risk analyses.
  • Manages the generation and completion of protocols and reports for test method validations.
  • Collaborates with Manufacturing Engineers to review processes for new and existing products, coordinating process validations and capability studies, and recommending monitoring devices when appropriate.
  • Develops inspection techniques and procedures to ensure product integrity in line with design specifications, responsible for writing, approving, and implementing Incoming, In-Process, and Final Inspection procedures.
  • Ensures that the disposition of non-conforming materials meets all regulatory requirements and that corrective actions are adequate to prevent recurrence.

Requirements:

  • Relevant experience in Quality Assurance Engineering
  • Bachelor's Degree in a Science-related field
  • Over 3 years of experience in a cleanroom environment
  • Strong background in medical device manufacturing
  • Solid understanding of statistical tools and the effective use of Design of Experiments (DOE) for recommendations
  • Excellent communication and interpersonal skills
  • Familiarity with FDA regulations, EU MDR, ISO 13485:2015, 21 CFR, and cGMPs

What's Included in the Offer:

  • Competitive base salary ranging from $80,000 to $95,000, based on experience and skills
  • Bonus potential of up to 5%
  • Comprehensive benefits package that includes medical, dental, and vision coverage
  • Life and Accidental Death & Dismemberment (AD&D) insurance
  • Short-term disability coverage
  • 15 days of paid time off (PTO) plus 10 holidays
  • 401(k) plan with a 6% company match


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