Senior Medical Device Quality Auditor

Masimo Corporation; Johor Bahru; On-site; MYR 50,000 - 80,000; Full time

Job summary

Masimo Corporation is seeking a Quality Assurance Auditor to plan, conduct, document, and report internal QMS audits, ensuring compliance with ISO 13485, 21 CFR Part 820, and EU MDR. This role collaborates with cross-functional teams to identify risks and drive continuous improvement across the organization.

The ideal candidate will have at least five years of internal audit experience in medical devices or pharma, strong regulatory knowledge, and excellent communication skills to support audits

Qualifications

• Minimum of five years conducting internal audits in medical devices or pharma.
• Strong knowledge of QMS and auditing principles incl. MDSAP.
• Thorough ISO 13485, 21 CFR 820, EU MDR 2017/745 understanding.
• Experience with CAPA, risk management and quality improvements.
• Excellent written and verbal communication.

Responsibilities

• Plan, conduct, and document internal QMS audits per schedules.
• Evaluate regulatory compliance and effectiveness of QMS processes.
• Prepare audit plans, communicate objectives, and document findings.
• Coordinate CAPAs and verify corrective actions.
• Support customer and regulatory audits through documentation.
• Maintain audit records per procedures and regs.
• Collaborate with cross-functional teams to drive improvements.
• Monitor regulatory changes and ensure ongoing compliance.
• Contribute to quality metrics and management reviews.

Skills

Audit planning

Regulatory knowledge

CAPA management

Analytical skills

Communication

Education

Bachelor's degree in a related field

Tools

MS Office

Electronic QMS

ERP systems

Job description

Masimo Corporation is seeking a Quality Assurance Auditor to plan, conduct, document, and report internal QMS audits, ensuring compliance with ISO 13485, 21 CFR Part 820, and EU MDR. This role collaborates with cross-functional teams to identify risks and drive continuous improvement across the organization.

The ideal candidate will have at least five years of internal audit experience in medical devices or pharma, strong regulatory knowledge, and excellent communication skills to support audits