Senior Quality Systems Engineer - CAPA & Compliance

Boston Scientific; Penang; On-site; MYR 284,784 - 366,151; Full time

Job summary

Boston Scientific in Penang, Malaysia, is looking for a qualified professional to ensure compliance with quality systems and regulatory requirements. This role involves leading audits, supporting CAPA processes, and driving continuous improvement initiatives.

Applicants should possess a Bachelor’s Degree and a minimum of 9 years of experience, ideally in the medical device industry. Knowledge of ISO 13485 and FDA regulations is essential.

Qualifications

• Minimum 9 years of experience in a manufacturing environment.
• Experience in the medical device industry is desirable.

Responsibilities

• Ensure compliance with internal quality systems and external regulatory requirements.
• Lead and support external inspections and regulatory audits.
• Plan, coordinate, and conduct internal audits.
• Identify areas of non-compliance and drive continuous improvement initiatives.
• Act as subject matter expert (SME) for CAPA processes.

Skills

Knowledge of ISO 13485

Knowledge of FDA regulations

Non-conformance management

CAPA management

Lead Auditor certification

Education

Bachelor’s Degree in Science, Engineering, or related field

Job description

Boston Scientific in Penang, Malaysia, is looking for a qualified professional to ensure compliance with quality systems and regulatory requirements. This role involves leading audits, supporting CAPA processes, and driving continuous improvement initiatives.

Applicants should possess a Bachelor’s Degree and a minimum of 9 years of experience, ideally in the medical device industry. Knowledge of ISO 13485 and FDA regulations is essential.