Quality Assurance Analyst 2

21 DexCom Malaysia Sdn Bhd; Penang; On-site; MYR 60,000 - 110,000; Full time

Job summary

Dexcom is seeking a Quality Assurance Analyst 2 to maintain and improve the Quality Management System (QMS) in line with ISO 13485, FDA QMSR, and other regulatory standards. The role partners with cross-functional teams to strengthen quality culture and compliance excellence across audits, CAPA, and regulatory submissions.

The position involves data analysis, metrics reporting, and driving continuous improvement initiatives, with travel up to 25% as needed for audits and inspections.

Qualifications

• Bachelor's Degree in Quality, Engineering, Science, or related discipline.
• 2–5 years in Quality Assurance or a regulated industry (medical device or pharma preferred).
• Knowledge of global medical device regulations (FDA QMSR, ISO 13485, MDSAP, EU MDR, regional regs).
• Experience supporting regulatory inspections, audit hosting, and inspection readiness.
• Strong CAPA, nonconformance, change control, and quality investigations.

Responsibilities

• Quality Compliance & QMS Support; maintain and improve QMS processes.
• Support Document Control, Change Control and Training System activities.
• Review and maintain quality procedures, documents, records, and training requirements.
• Collaborate with cross-functional teams to document, review, approve, and implement changes.
• Support/QMS Improvement Projects including Process Optimization and Document Control System enhancements.
• Perform Data Analysis and Reporting to monitor QMS performance.

Skills

Quality Assurance

Data analysis

Regulatory knowledge

Cross-functional

CAPA handling

Education

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

Tools

Power BI

Excel

QMS systems

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 Quality Assurance Analyst 2

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 QMSR, MDSAP, and company requirements.

Support Document Control, Change Control and Training System activities, ensuring timely and compliant execution.

Review and maintain quality procedures, documents, records, and training requirements.

Collaborate with cross-functional teams to ensure changes are appropriately documented, reviewed, approved, and implemented.

Support/ Drive QMS Improvement Project including Process Optimization and Document Control System enhancement.

Perform Data Analysis and Reporting to monitor QMS performance and identify improvement opportunities.

Participate in audit readiness, quality compliance and regulatory programs.

Audit & Inspection Readiness Support internal audits, external audits, walkthroughs, line walks, and mock audits.

Coordinate audit preparation, documentation, 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

Support investigations related to CAPA, nonconformances, deviations, and complaints.

Apply root cause analysis and problem-solving methodologies to support effective corrective and preventive actions.

Monitor and trend quality events to identify systemic issues and improvement opportunities.

Support 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 QMS 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 2–5 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 QMSR, ISO 13485, MDSAP, EU MDR, and applicable regional regulations.
• Experience supporting regulatory inspections, audit hosting, and inspection readiness activities.
• Strong understanding and hands-on experience with CAPA, Nonconformance, Change Control, and quality investigation processes.
• Strong analytical, problem-solving, organizational, and communication skills.
• Experience with quality metrics, data analysis, and reporting tools.
• Experience in Document Control, QMS projects, or regulatory/site registration activities.
• 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 certifications.
• Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Lead Auditor certification.

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].

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.