Quality Assurance Analyst II — QMS & Regulatory Readiness

Dexcom; George Town; On-site; MYR 60,000 - 120,000; Full time

Job summary

Dexcom is seeking a Quality Assurance Analyst 2 in Penang, Malaysia, to maintain and improve the QMS for regulatory compliance. You will support CAPA, complaint investigations, and regulatory submissions while partnering with cross-functional teams to strengthen quality culture and process excellence.

The role requires thorough knowledge of global medical device regulations, strong analytical skills, and proactive data-driven decision making with tools like Power BI and Excel.

Qualifications

• Bachelor’s Degree in Quality, Engineering, Science, or related field.
• 2–5 years in Quality Assurance or regulated industry (medical device/pharma preferred).
• Knowledge of FDA QMSR, ISO 13485, MDSAP, EU MDR and regional regs.
• Experience supporting regulatory inspections and audit readiness.
• Strong CAPA, Nonconformance, Change Control and quality investigations.
• Analytical, problem-solving, organizational and communication skills.
• Experience with quality metrics, data analysis and reporting tools.
• Document Control, QMS projects, or regulatory/site registration experience.
• Ability to work with cross-functional teams and manage multiple priorities.

Responsibilities

• Support, maintain and improve QMS processes for compliance.
• Review and update quality procedures, documents and records.
• Collaborate with cross-functional teams to document, review and implement changes.
• Assist in CAPA, nonconformance, deviations and investigations.
• Monitor QMS performance with data analysis and reporting.
• Support regulatory submissions and responses to agencies.

Skills

Quality Assurance

Analytical Skills

Cross-Functional

Data Analysis

Problem Solving

Communication Skills

Education

Bachelor’s Degree

Tools

Power BI

Excel

Job description

Dexcom is seeking a Quality Assurance Analyst 2 in Penang, Malaysia, to maintain and improve the QMS for regulatory compliance. You will support CAPA, complaint investigations, and regulatory submissions while partnering with cross-functional teams to strengthen quality culture and process excellence.

The role requires thorough knowledge of global medical device regulations, strong analytical skills, and proactive data-driven decision making with tools like Power BI and Excel.