Senior Quality Systems Auditor & CAPA Lead

Boston Scientific; George Town; On-site; MYR 180,000 - 240,000; Full time

Job summary

Boston Scientific Penang QA team is seeking a senior auditor to lead internal and external audits, ensuring compliance with FDA, ISO, cGMP and MDR. The role focuses on CAPA, process controls and continuous improvement across quality systems.

You will drive CAPA metrics, support corrective actions, and educate cross-functional teams on quality requirements, potentially traveling to support other sites as needed.

Qualifications

• Degree in science, engineering or related discipline.
• Minimum 9 years in quality/audit roles.
• Experience in medical device industry is desirable.
• Strong knowledge of regulatory standards and CAPA processes.

Responsibilities

• Lead audits internal and external to ensure compliance with FDA, ISO, cGMP and MDR.
• Coordinate and conduct scheduled audits; investigate findings and CAPA actions.
• Maintain CAPA processes and metrics for management review.
• Educate and align functional areas on quality system requirements.
• Support regulatory and quality assurance activities across Penang site.

Skills

Quality systems

Auditing expertise

CAPA management

Regulatory compliance

Cross-functional leadership

Education

Degree in Science or Engineering

Tools

Lead Auditor qualification

Job description

Boston Scientific Penang QA team is seeking a senior auditor to lead internal and external audits, ensuring compliance with FDA, ISO, cGMP and MDR. The role focuses on CAPA, process controls and continuous improvement across quality systems.

You will drive CAPA metrics, support corrective actions, and educate cross-functional teams on quality requirements, potentially traveling to support other sites as needed.