Quality Compliance Specialist - Medical Industry Background

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

Quality Compliance Specialist - Medical Industry Background

The Quality Compliance Specialist is responsible for investigating customer complaints, ensuring accurate documentation, and supporting regulatory compliance. This role involves complaint evaluation, reporting decisions, coordination of investigations, and ensuring adherence to global medical device regulations.

Job Summary

The Quality Compliance Specialist is responsible for investigating customer complaints, ensuring accurate documentation, and supporting regulatory compliance. This role involves complaint evaluation, reporting decisions, coordination of investigations, and ensuring adherence to global medical device regulations.

Key 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
• Coordinate product investigations and follow up with internal teams and customers
• Prepare and document customer responses related to complaints
• Monitor complaint trends and support risk management activities
• Ensure compliance with company procedures and quality system requirements

Requirements & Qualifications

• Strong organizational and documentation skills
• Ability to prioritize tasks and work independently
• Effective communication skills (written and verbal) in English
• Proficient in Microsoft Office applications
• Detail-oriented with strong analytical and decision-making skills
• Team player with the ability to interact with internal and external stakeholders

Work Environment

• Office-based role with regular use of computers and digital tools
• Occasional local travel may be required