QA & QC Lead, Medical Devices (ISO 13485)

MADEWELL MEDICAL TECHNOLOGY (MALAYSIA) SDN. BHD.; Baling; On-site; MYR 100,000 - 150,000; Full time

Job summary

A medical technology company located in Baling, Kedah is seeking a professional to oversee the quality management system of the company. The ideal candidate will ensure compliance with ISO 13485 and medical regulatory requirements, supervise product quality throughout production processes, handle customer complaints, and lead audits and inspections. Strong experience in quality management systems is essential for this role.

Qualifications

• Experience with quality management systems.
• Knowledge of ISO 13485 and medical regulations.

Responsibilities

• Responsible for the overall QC & QA quality management system of the company.
• Ensure compliance with ISO 13485 and medical regulatory requirements.
• Supervise incoming materials, production processes, and finished product quality.
• Handle customer complaints and non-conforming products.
• Lead internal and external audits as well as regulatory inspections.

Job description

A medical technology company located in Baling, Kedah is seeking a professional to oversee the quality management system of the company. The ideal candidate will ensure compliance with ISO 13485 and medical regulatory requirements, supervise product quality throughout production processes, handle customer complaints, and lead audits and inspections. Strong experience in quality management systems is essential for this role.