Postmarket Quality Manager

Added
2 minutes ago
Type
Full time
Salary
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Related skills

quality assurance fda medical device clinical laboratory ivd

📋 Description

  • Own the end-to-end complaint handling process — from intake and triage through technical
  • Own the CAPA program: ensure that complaints, non-conformances, and laboratory quality events drive
  • Serve as the escalation point and technical mentor for junior team members managing
  • Serve as the primary Quality liaison to commercial partners and customer-facing teams as it relates
  • Monitor and analyze complaint, CAPA, and non-conformance trends across all quality event streams
  • Compile and present quality signals data: complaint volumes, CAPA quantities and their status

🎯 Requirements

  • Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
  • 7+ years of quality assurance experience with direct ownership of a complaint handling or
  • Working knowledge of CAP/CLIA laboratory complaint and quality event requirements and how they
  • Hands-on CAPA program experience: root cause analysis, corrective action implementation
  • Demonstrated ability to mentor or develop junior quality staff — someone who builds capability in
  • Experience interfacing with external customers or commercial partners on complaint intake

🎁 Benefits

  • Base salary range: $134,425 - $170,100
  • Equity, cash bonuses, and a full range of medical, financial, and other benefits
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