Sr Quality Assurance Analyst

Location: Penang, Malaysia

Remote Type: Assigned Desk

Time Type: Full time

Job Description

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 Senior Quality Analyst plays a key role in supporting Quality Management System (QMS) enhancements, coordinating audits, managing customer complaints, and performing advanced data analysis to identify trends and drive continuous improvement. Exposure to Post-Market Surveillance (PMS) and Field Action processes is considered an advantage. Additionally, the role supports in-house quality issue investigations through Nonconformance and CAPA processes. This position requires strong analytical skills and experience in complaint handling within the medical device or pharmaceutical industry.

Essential Duties and Responsibilities:

Data‑Driven Quality & Continuous Improvement (Core Emphasis)

• Lead the analysis of quality data across nonconformances, CAPA, complaints and audits to identify trends, systemic risks, and improvement opportunities.
• Develop and maintain Power BI dashboards and analytical reports to monitor key quality indicators (CAPA aging, repeat issues, audit trends, complaint signals).
• Apply statistical and analytical tools (e.g., Power BI, Minitab, advanced Excel) to support predictive insights, risk prioritization, and management review.
• Translate complex data into clear, actionable insights for leadership, cross‑functional teams, and regulatory discussions.

Nonconformance, CAPA & Complaint Management

• Lead and support investigations of nonconformances, deviations, and customer complaints, ensuring robust root cause analysis and effective CAPA implementation.
• Ensure CAPAs are data‑driven, risk‑based, and verified for effectiveness, with timely closure in compliance with regulatory and QMS requirements.
• Trend CAPA and complaint data to identify recurring issues and drive preventive actions across the system.

Risk Management

• Support and maintain risk management activities (e.g., ISO 14971), including updates based on complaint trends, audit findings, and process changes.
• Ensure feedback loops between CAPA, and risk management are effective and traceable.

Quality Management System (QMS) Ownership & Enhancement

• Maintain and continuously improve QMS processes to ensure compliance with ISO 13485, FDA QSR (21 CFR 820), and applicable regulatory requirements.
• Support QMS process ownership, including document control, training, change management, CAPA, and audit management.
• Drive QMS improvements using Lean and Six Sigma principles, eliminating non‑value‑added activities while maintaining compliance.

Audit & Inspection Readiness

• Plan, coordinate, and support internal audits, supplier audits, and external regulatory inspections (FDA, Notified Bodies, MDSAP).
• Prepare audit metrics, dashboards, and evidence packages using data‑driven approaches.
• Lead or support responses to audit observations, ensuring corrective actions are tracked, trended, and closed effectively.

Cross‑Functional Collaboration & Capability Building

• Partner with Quality, Regulatory, Operations, Engineering, and Global teams to align on quality objectives and risk priorities.
• Provide training and coaching on CAPA, complaint handling, risk management, and data analytics best practices.
• Act as a quality data SME, promoting a culture of fact‑based decision‑making.

Required Qualifications:

• Bachelor’s degree in Engineering, Science, Statistic or related discipline.
• Minimum 8–10 years of experience in Quality Engineering and/or Quality Systems within a regulated medical device environment.
• Strong working knowledge of ISO 13485, 21 CFR 820, ISO 14971, and EU MDR, with hands‑on audit and inspection support experience.
• Demonstrated expertise in data analysis and visualization, including Power BI and statistical tools.
• Excellent communication, analytical thinking, and stakeholder‑management skills.

Preferred Qualifications:

• Lean, Six Sigma, or equivalent continuous improvement certification.
• Proficiency in Power BI for dashboard development and data visualization.

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.