Quality Assurance Specialist

4 weeks ago


Denver, Colorado, United States Michael Page Full time

**Quality Assurance Specialist**

We are seeking a Quality Assurance Specialist to contribute to the success of our global medical device product line utilized in surgeries.

In this role, you will be responsible for customer communication, root cause analysis, corrective actions, and leading initiatives on the production floor to enhance efficiency.

The Quality Assurance Specialist will be responsible for:

  • 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.
  • 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
  • Strong background in medical device manufacturing

**What We Offer**

  • Comprehensive benefits package that includes medical, dental, and vision coverage
  • Short-term disability coverage
  • 15 days of paid time off (PTO) plus 10 holidays


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