QA Analyst II - QMS & Regulatory Readiness

21 DexCom Malaysia Sdn Bhd; Penang; Vor Ort; MYR 60.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

Data analysis

Regulatory knowledge

Cross-functional

CAPA handling

Ausbildung

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

Tools

Power BI

Excel

QMS systems

Jobbeschreibung

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.