Job Description :
Title: Quality Assurance Specialist
Pay Rate: $38-$40/hour
Assignment Length: 1-year assignment covering for a leave of absence
Schedule: Monday to Friday, 8:00 AM - 5:00 PM
Location: Rocklin site (please note the site is closing in Q2 2026)
Qualifications:
  • Bachelor's Degree required.
  • Minimum of 2 years of experience in quality assurance or a related field.
  • Proficiency in risk management/assessment (specifically for medical devices), validation, and data control/integrity.
  • Experience with SAP and Trackwise is a plus.
Key Responsibilities:
  • Support the site's Quality Management System (QMS) and ensure compliance with relevant regulations and standards, including:
    • ISO 13485
    • IVDR (EU)
    • IVDD (EU)
    • 21 CFR Part 20 and Part 11
    • ISO 14971
    • GxP requirements
  • Represent the Quality department on cross-functional teams to support business objectives.
  • Lead quality initiatives to foster a positive site Quality culture.
  • Prepare and manage Quality System (QS) documentation and reports to support routine operations, including site metrics and management reviews.
             

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