QA/QC Lead - Medical Devices & Compliance

Asia Medsource Group; Kuala Lumpur; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical device manufacturer in Kuala Lumpur is seeking an experienced Quality Assurance / Quality Control professional to oversee quality management functions, ensure compliance with local and international standards, and lead a quality control team. You will collaborate with various teams to maintain product quality, conduct audits, and manage customer feedback efficiently. The ideal candidate holds a Bachelor's degree and has at least five years of relevant experience in the disposable medical device industry.

Qualifications

• Minimum of five years of relevant experience in Operations/Process Improvement/Quality in disposable medical device manufacturing.
• Experience with ISO or equivalent quality management systems.
• Solid knowledge of FDA regulations, GMPs, ISO 13485, and related standards.
• Integrity, discipline, and adherence to principles.

Responsibilities

• Oversee quality management functions to ensure compliance with standards.
• Conduct audits for CSR and QMS to assess compliance.
• Collaborate with sourcing to ensure product developments meet quality standards.
• Manage customer feedback and implement corrective actions.

Skills

Proficiency in Mandarin

Solid English communication skills

Analytical skills

Attention to detail

Education

Bachelor's degree

Tools

MS Office Suite (Excel, Word)

Job description

A leading medical device manufacturer in Kuala Lumpur is seeking an experienced Quality Assurance / Quality Control professional to oversee quality management functions, ensure compliance with local and international standards, and lead a quality control team. You will collaborate with various teams to maintain product quality, conduct audits, and manage customer feedback efficiently. The ideal candidate holds a Bachelor's degree and has at least five years of relevant experience in the disposable medical device industry.