Sr Quality Assurance Analyst

Dexcom; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

Dexcom Malaysia is seeking a Senior Quality Analyst to strengthen the Quality Management System (QMS) and ensure compliance with regulatory requirements.

You will lead audits, CAPA, and regulatory submission support while partnering with cross-functional teams to improve quality culture and continuous improvement.

The role emphasizes data-driven metrics and continuous improvement using Power BI and Excel.

Qualifications

• Bachelor's Degree in Quality, Engineering, Science, or a related discipline.
• Minimum 5–8 years of experience in Quality Assurance, Quality Compliance, or a regulated industry (Medical Device or Pharmaceutical preferred).
• Knowledge of global medical device regulations, including FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR, and applicable regional regulations.
• Experience supporting regulatory inspections, audit hosting, and inspection readiness activities.
• Strong analytical, problem-solving, organizational, and communication skills.

Responsibilities

• Maintain and improve QMS to ensure regulatory compliance.
• Lead internal and external audits, walkthroughs, and inspections with timely closure of findings.
• Lead investigations related to CAPA, nonconformances, deviations, and complaints; implement root cause analysis and corrective actions.
• Support regulatory submissions, product registrations, renewals, and change notifications.
• Analyze quality data, develop metrics, dashboards, and support management reviews.

Skills

Quality Assurance

Regulatory knowledge

Analytical skills

Cross-functional collaboration

Education

Bachelor's Degree in Quality, Engineering, Science, or related

Tools

Power BI

Excel

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.

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 is responsible for maintaining and continuously improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role serves as a key contributor to audit readiness, CAPA management, complaint investigations, regulatory submission support, management review, quality metrics, and continuous improvement initiatives, while partnering with cross-functional teams to strengthen quality culture and compliance excellence.

Essential Duties And Responsibilities

Quality Compliance & QMS

• Support, maintain, and improve QMS processes to ensure compliance with ISO 13485, FDA QSR/QMSR, MDSAP, and company requirements.
• Review and update quality procedures, records, and documentation.
• Support Change Control activities and drive quality system improvements.
• Participate in quality compliance initiatives and regulatory compliance programs.

Audit & Inspection Readiness

• Lead and support internal audits, external audits, walkthroughs, line walks, and mock audits.
• Coordinate audit activities, responses, and timely closure of audit findings.
• Support regulatory inspections and maintain site audit readiness.
• Provide guidance and coaching to process owners on compliance requirements

CAPA, Nonconformance & Complaint Management

• Lead investigations related to CAPA, nonconformances, deviations, and complaints.
• Perform root cause analysis and ensure effective corrective and preventive actions are implemented.
• Monitor and trend quality events to identify systemic issues and improvement opportunities.
• Ensure timely closure and effectiveness verification of CAPAs.

Regulatory Submission Support

• Support regulatory submissions, product registrations, renewals, and change notifications.
• Prepare, review, and provide quality documentation required for regulatory submissions.
• Assess the quality and compliance impact of product, process, supplier, and manufacturing changes.
• Support responses to regulatory agencies, notified bodies, and customer inquiries

Quality Metrics & Management Review

• Analyze quality data and develop metrics, dashboards, and reports.
• Monitor KPI trends and recommend improvement actions.
• Support Site Management Review and Quality Review meetings through data analysis and presentation of quality performance.
• Utilize analytical tools such as Power BI, Excel, and other reporting platforms to support decision-making.

Required Qualifications

• Bachelor's Degree in Quality, Engineering, Science, or a related discipline.
• Minimum 5–8 years of experience in Quality Assurance, Quality Compliance, or a regulated industry (Medical Device or Pharmaceutical preferred).
• Knowledge of global medical device regulations, including FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR, and applicable regional regulations.
• Experience supporting regulatory inspections, audit hosting, and inspection readiness activities.
• Strong analytical, problem-solving, organizational, and communication skills.
• Experience with quality metrics, data analysis, and reporting tools.
• Ability to work effectively with cross-functional teams and manage multiple priorities.

Preferred Qualifications

• Understanding of regulatory submissions, product registrations, renewals, and change notification requirements.
• Experience with Power BI, quality metrics, data visualization, and trend analysis.
• Lean, Six Sigma, or other Continuous Improvement certification.
• Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Lead Auditor certification are desirable.

Travel Required

• Up to 25% travel, as required for audits, training, benchmarking, or cross-site collaboration.

AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].