Staff Quality Assurance Analyst

Dexcom Inc

Penang, Malaysia
On-site
Capa, nonconformance, complaint handling, hha expertise
Quality management system (qms)
Risk-based thinking
Dexcom Inc. is seeking a Staff Quality Assurance Analyst to lead efforts in CAPA, nonconformance, complaint handling, and health hazard assessment within their Quality Management System. The ideal candidate will possess extensive experience in quality assurance within a regulated medical device environment and demonstrate strong analytical and coaching skills

Job Summary

  • This role leads complex investigations and serves as a CAPA and HHA Coach, strengthening investigation quality and regulatory robustness.
  • Perform advanced analysis and trending of QMS data to identify systemic risks and emerging signals, presenting data-driven insights to leadership.
  • Serve as a key Quality SME during audits and regulatory inspections, driving closure of observations through strong CAPA and HHA execution.

Matching Summary

Match Score: 85

Dexcom Inc. is seeking a Staff Quality Assurance Analyst to lead efforts in CAPA, nonconformance, complaint handling, and health hazard assessment within their Quality Management System. The ideal candidate will possess extensive experience in quality assurance within a regulated medical device environment and demonstrate strong analytical and coaching skills.

Skills & Requirements

Must-have

  • CAPA, Nonconformance, Complaint Handling, HHA expertise
  • Quality Management System (QMS)
  • Risk-based thinking
  • Data-driven insights
  • ISO 13485, FDA QSR (21 CFR 820)

Nice-to-have

  • Coaching and mentoring junior analysts
  • Cross-functional influence
  • Audit readiness and support
  • Continuous improvement initiatives

Key Requirements

  • Bachelor’s degree in Engineering, Science, Quality, or related discipline
  • Minimum 10 years of experience in Quality Assurance/Compliance
  • Demonstrated experience coaching or mentoring others
  • Advanced analytical skills using Power BI, Excel, or statistical tools
  • Lean, Six Sigma, or Root Cause Analysis certification (preferred)
  • Experience facilitating CRB and HHA review forums (preferred)

Work Rights

Not specified

Tailored Resume

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