Quality Assurance Manager Job at BioTalent, Sunnyvale, CA

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  • BioTalent
  • Sunnyvale, CA

Job Description

Quality Assurance Manager – Medical Device - 5 Days Onsite Requirement

A fast-growing medical device company is seeking a Quality Manager to lead day-to-day operations across Quality Assurance, Quality Operations Engineering, Calibration, and Receiving Inspection functions.

Key Responsibilities:

  • Oversee inspection activities for incoming materials and assembled products
  • Manage and allocate team resources to meet production and quality goals
  • Hire, train, and evaluate QA/QC staff
  • Ensure compliance with GMP, GDP, and internal procedures
  • Support cleanroom environmental monitoring and calibration programs
  • Collaborate with manufacturing and supplier quality to resolve quality issues
  • Lead inspection test method validations and drive continuous improvement
  • Maintain and report on department metrics and audit readiness

Qualifications:

  • Bachelor’s degree in Engineering or related field
  • 10+ years in the medical device industry
  • 3–4 years of direct team management experience

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