Staff Quality Assurance Analyst

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Summary:

The Staff QA Analyst is a recognized Subject Matter Expert (SME) for CAPA, Nonconformance, Complaint Handling, and Health Hazard Assessment (HHA) within the Quality Management System (QMS). Operating with a high degree of autonomy and professional judgment, this role not only leads complex investigations but also serves as a CAPA and HHA Coach, strengthening investigation quality, risk‑based thinking, and regulatory robustness across the QA analyst community. This role influences quality outcomes beyond individual tasks, drives systemic improvement through data‑driven insights, and builds organizational capability through structured coaching and governance—without formal people management responsibility.

Essential Duties and Responsibilities:

CAPA Leadership & Coaching (Senior‑Level Differentiator)

• Act as CAPA SME and Coach, providing hands‑on guidance to junior QA Analysts on:
  • Clear problem statements and issue framing
  • Robust root cause analysis
  • Risk‑based corrective and preventive actions
  • Verification of effectiveness (VoE)
• Review CAPA records for depth, linkage, and regulatory robustness in alignment with CAPA rubric and CRB expectations.
• Lead or co‑facilitate CAPA Review Board (CRB) discussions, challenging weak investigations and driving higher investigation quality.
• Identify recurring CAPA execution gaps and proactively develop coaching materials, templates, or focused training sessions to uplift team capability.
   

HHA (Health Hazard Assessment) Coordination & Coaching

• Serve as HHA Coordinator, overseeing end‑to‑end HHA activities arising from complaints, nonconformances, CAPA, or field issues.
• Guide cross‑functional teams through HHA execution, ensuring:
  • Appropriate hazard identification and risk characterization
  • Consistent application of risk‑based decision‑making
  • Clear linkage between HHA outcomes, CAPA, and Field Action decisions
• Act as HHA Coach, mentoring junior QA Analysts on:
  • When HHA is required
  • How to document risk rationale clearly and defensibly
  • How to present HHA conclusions during audits or management review
• Ensure HHA records are complete, traceable, and inspection‑ready, aligned with regulatory and QMS expectations.

Advanced Quality Data Analysis & Trending

• Perform advanced analysis and trending of CAPA, NCMR, complaint, HHA, audit, and PMS data to identify systemic risks and emerging signals.
• Develop and maintain Power BI dashboards and analytical reports to monitor:
  • CAPA aging and recurrence
  • Investigation quality indicators
  • HHA triggers and outcomes
• Present data‑driven insights and recommendations to Quality leadership, Site Management Review, and cross‑functional forums.
   

Complaint, Nonconformance & PMS Oversight

• Lead complex complaint and nonconformance investigations, particularly those with patient safety, regulatory, or cross‑site impact.
• Ensure effective linkage between complaints, CAPA, HHA, PMS, and risk management, escalating emerging risks appropriately.
• Coach junior analysts on risk‑based thinking, documentation discipline, and regulatory mindset.

QMS & Audit SME Support

• Serve as a key Quality SME during internal audits, external audits, and regulatory inspections, especially for CAPA, HHA, and investigation‑related topics.
• Support audit readiness by ensuring consistent application of QMS requirements and high‑quality investigation records.
• Drive closure of audit observations through strong CAPA and HHA execution, including coaching of responsible owners.
   

Cross‑Functional Influence & Capability Building

• Partner with Operations, Engineering, Regulatory, and Global Quality teams to resolve systemic quality and safety issues.
• Contribute to quality capability‑building initiatives, including CAPA/HHA workshops, best‑practice sharing, and onboarding support for new QA Analysts.
• Influence outcomes through expert judgment, coaching, and data‑based recommendations, rather than positional authority.

Required Qualifications:

• Bachelor’s degree in Engineering, Science, Quality, or related discipline.
• Minimum 10 years of experience in Quality Assurance / Quality Compliance within a regulated medical device environment.
• Strong hands‑on expertise in CAPA, Nonconformance, Complaint Handling, and HHA.
• Demonstrated experience coaching or mentoring others in investigation quality and risk assessment.
• Advanced analytical skills using Power BI, Excel, or statistical tools.
• Strong working knowledge of ISO 13485, FDA QSR (21 CFR 820), and risk management principles.

Preferred Qualifications:

• Lean, Six Sigma, or Root Cause Analysis certification.
• Experience facilitating CRB and HHA review forums.
• Experience with electronic QMS platforms (e.g., IQVIA SmartSolve).
• Knowledge of software validation requirements is an added advantage.

Education Requirements:

• Bachelor’s degree in Quality, Engineering, Sciences, Statistic, or related field.
• Advanced degree or professional certifications (e.g., ASQ CQE, CQA) is a plus.

Travel Required:

• 0 – 25%

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.