Senior Quality Systems Engineer — Audit & CAPA Lead

Boston Scientific; Penang; On-site; MYR 180,000 - 300,000; Full time

Job summary

Boston Scientific Penang is seeking a seasoned quality assurance professional to oversee internal and external audits, CAPA, and regulatory compliance in a medical device environment. The role ensures adherence to FDA, ISO 13485, EU MDR, and cGMP standards, driving continuous improvement across multiple functions.

The incumbent will lead audit programs, support CAPA processes, and educate teams on quality system requirements, with occasional travel to support global sites.

Qualifications

• Degree qualified in Science, Engineering, or a related discipline.
• Minimum 9 years of experience in quality background.
• Experience in the medical device industry is desirable.
• Experience in Non-Conforming Events and CAPA management.
• Experience in Internal Audit and External Audit activities.
• Experience in Management Review processes.
• Strong understanding of quality systems, regulatory compliance, and continuous improvement methodologies.
• Ability to work cross-functionally and drive quality system initiatives across the organization.

Responsibilities

• Implement internal requirements, external laws, regulations, guidances and standards for Boston Scientific quality systems.
• Lead internal auditing techniques and ensure compliance with FDA, ISO, cGMP and MDR.
• Lead and support site External Inspections.
• Plan, coordinate and conduct scheduled audits to assess compliance with FDA, ISO, cGMP and MDR.
• Identify areas of potential noncompliance or improvements via internal audits.
• Attend global conference calls and meetings related to the internal audit process.
• Lead CAPA systems to meet internal and external requirements.
• Support site corrective and preventive actions process.
• Maintain the Penang CAPA process and develop CAPA metrics for management review.
• Educate functional areas on quality system requirements and standardize policies.

Skills

ISO 13485

FDA Regulations

EU MDR

cGMP

CAPA systems

Regulatory compliance

Quality metrics analysis

Audit management

Education

Degree in Science or Engineering

Job description

Boston Scientific Penang is seeking a seasoned quality assurance professional to oversee internal and external audits, CAPA, and regulatory compliance in a medical device environment. The role ensures adherence to FDA, ISO 13485, EU MDR, and cGMP standards, driving continuous improvement across multiple functions.

The incumbent will lead audit programs, support CAPA processes, and educate teams on quality system requirements, with occasional travel to support global sites.