Medical Device Quality Compliance Specialist

Masimo.; Pasir Gudang; On-site; MYR 45,000 - 65,000; Full time

Job summary

A leading medical device company in Johor, Malaysia, is seeking a Quality Compliance Specialist to investigate customer complaints, ensure regulatory compliance, and support quality assurance processes. Candidates should have strong organizational skills, be detail-oriented, and possess effective communication abilities in English. This office-based role requires proficiency in Microsoft Office and the ability to work both independently and as part of a team. Occasional local travel may be necessary.

Responsibilities

• Investigate and manage customer complaints in a timely and compliant manner.
• Perform initial regulatory reportability assessments (FDA, MEDDEV, Health Canada, etc.).
• Ensure complete, accurate, and consistent complaint documentation.

Skills

Strong organizational and documentation skills

Effective communication skills (written and verbal) in English

Detail-oriented with strong analytical and decision-making skills

Ability to prioritize tasks and work independently

Team player with the ability to interact with internal and external stakeholders

Proficient in Microsoft Office applications

Job description

A leading medical device company in Johor, Malaysia, is seeking a Quality Compliance Specialist to investigate customer complaints, ensure regulatory compliance, and support quality assurance processes. Candidates should have strong organizational skills, be detail-oriented, and possess effective communication abilities in English. This office-based role requires proficiency in Microsoft Office and the ability to work both independently and as part of a team. Occasional local travel may be necessary.