Senior QA Lead - QMS & Regulatory Compliance Expert

Dexcom Inc.; Penang; On-site; MYR 90,000 - 150,000; Full time

Job summary

Dexcom Inc. in Malaysia is seeking a Senior Quality Analyst responsible for maintaining and improving the Quality Management System to ensure regulatory compliance and alignment with company procedures.

You will lead audit readiness, CAPA management, complaint investigations, and regulatory submission support while partnering with cross-functional teams to strengthen quality culture and compliance excellence.

Qualifications

• Bachelor’s Degree in Quality, Engineering, Science, or related discipline.
• Minimum 5–8 years in Quality Assurance or regulated industry (Medical Device/Pharma preferred).
• Knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR, and regional regs.
• Experience supporting regulatory inspections, audit hosting, and inspection readiness.

Responsibilities

• Maintain, improve and ensure QMS compliance with ISO 13485, FDA QSR/QMSR, MDSAP, EU MDR, and company requirements.
• Lead internal and external audits, walkthroughs, line walks, and mock audits; coordinate responses and closure of findings.

Skills

Quality Assurance

Regulatory compliance

Audits

CAPA

Data analysis

Power BI

Excel

Cross-functional teamwork

Problem solving

Communication

Education

Bachelor's Degree in Quality/Engineering/Science

Tools

Power BI

Excel

Job description

Dexcom Inc. in Malaysia is seeking a Senior Quality Analyst responsible for maintaining and improving the Quality Management System to ensure regulatory compliance and alignment with company procedures.

You will lead audit readiness, CAPA management, complaint investigations, and regulatory submission support while partnering with cross-functional teams to strengthen quality culture and compliance excellence.