Assistant Manager – Quality Assurance – Medical Devices

About the role

MAS Holdings is seeking an Assistant Manager to lead the Quality Assurance function for its Medical Devices portfolio within the Bodywear Value Stream. You will ensure compliance with international quality standards, drive product safety, and support the delivery of high‑quality medical and feminine‑hygiene apparel.

Key responsibilities

• Implement and maintain ISO 13485, GMP, and ISO 22716 quality management systems.
• Optimize quality systems to meet brand and customer requirements.
• Conduct Product & Process FMEA and Hygiene FMEA to mitigate risks.
• Execute audit programmes (1st 10 pcs, 1st 100 pcs, inline, end‑line, pre‑final, final).
• Prevent mould growth in merchandise through proactive mould‑prevention measures.
• Collaborate with certification bodies and obtain lead‑auditor certification.
• Analyse customer complaints and develop corrective and preventive actions.
• Maintain traceability compliance via traceability audits and Device History Records (DHR) upkeep.
• Support capacity planning and qualify subcontract plants for brand accreditation.
• Deploy Built‑in Quality (BIQ) principles across projects.

Required profile

• Proven experience in quality assurance for medical devices or regulated apparel.
• Strong knowledge of ISO 13485, GMP, ISO 22716 and related regulatory frameworks.
• Hands‑on experience with FMEA, audit execution, and traceability systems.
• Ability to work with internal teams and external certification bodies.
• Analytical mindset for complaint handling and problem‑solving.

Required skills

• ISO 13485 implementation
• GMP compliance
• ISO 22716 implementation
• Product & Process FMEA
• Hygiene FMEA
• Audit techniques (1st 10 pcs, 1st 100 pcs, inline, end‑line, pre‑final, final)
• Traceability audits
• Device History Records (DHR) maintenance
• Built‑in Quality (BIQ) principles