QA Engineer – Medical Devices, ISO 13485 & MDR

Welford Manufacturing; Malaysia; On-site; MYR 70,000 - 90,000; Full time

Job summary

A medical device manufacturer in Malaysia is seeking a Quality Assurance (QA) professional to manage quality-related activities and ensure compliance with international standards. The ideal candidate will have a Bachelor's degree in Engineering/Science, at least 4 years of QA/QC experience in medical device manufacturing, and strong communication skills in English and Bahasa Malaysia. Key responsibilities include maintaining quality documentation, tracking product performance, and leading audits. This position offers a dynamic work environment focused on quality improvement.

Qualifications

• 4+ years in QA/QC within medical device manufacturing (infusion sets/IV sets preferred).
• Expertise in ISO 13485, CE Marking, US FDA, Malaysia MDA.
• Experience with audits and root cause analysis.

Responsibilities

• Produce, coordinate, and maintain quality documentation per the Quality Management System (QMS).
• Track product quality and safety performance through reviews and surveillance.
• Perform and coordinate internal/external audits for compliance.

Skills

Strong communication in English & Bahasa Malaysia

Team player with ability to work independently

Computer literate (MS Office, QA software)

Education

Bachelor's degree in Engineering/Science or equivalent

Tools

QMS documentation

ISO 13485

CAPA documentation

Job description

A medical device manufacturer in Malaysia is seeking a Quality Assurance (QA) professional to manage quality-related activities and ensure compliance with international standards. The ideal candidate will have a Bachelor's degree in Engineering/Science, at least 4 years of QA/QC experience in medical device manufacturing, and strong communication skills in English and Bahasa Malaysia. Key responsibilities include maintaining quality documentation, tracking product performance, and leading audits. This position offers a dynamic work environment focused on quality improvement.