Quality Control Manager - Medical Device Garments

About the role

The Wearables and Growth Platforms team is building, scaling and commercialising wearable technology and medical device businesses. It is looking for a Quality Control Manager in Colombo to lead quality across the development and manufacture of soft goods for medical device garments, ensuring compliance with global regulatory standards.

Key responsibilities

• Establish, implement and maintain quality system processes aligned with ISO 13485 and GLP/GMP across product development and manufacturing.
• Ensure ongoing compliance with ISO 14971 (risk management) and regional regulations such as US FDA, EU MDR and TGA.
• Own regulatory audit readiness and act as a key contact during external and internal audits.
• Lead quality risk management across the product lifecycle, from design through manufacturing.
• Develop, implement and maintain quality control plans, including documentation review and approval processes.
• Design, verify and validate quality control test methodologies for soft goods and textile-based medical device garments.
• Drive quality involvement in new product integration and lead design transfer planning from development to manufacturing.
• Manage supplier quality and act as the primary quality liaison with contract manufacturers.
• Lead root cause analysis for quality issues and non-conformances, manage change control and CAPA, and set up ongoing monitoring and control mechanisms.
• Lead, manage and motivate a cross-functional quality team and report progress to leadership.

Required profile

• BEng, BSc, BTec or equivalent technical degree with a minor in management studies.
• Solid background in materials, textiles or garment development, manufacturing and quality control/testing.
• Proven people management experience leading teams in a technical or manufacturing setting.
• Hands-on experience implementing GLP/GMP and ISO 13485, ideally in medical devices or healthcare products.
• Track record managing supplier quality programs and contract manufacturer relationships.

Required skills

• Quality risk management, QC planning and execution, and documentation control.
• Experience developing and validating QC test methods.
• Root cause analysis, CAPA and change control.
• Building and reporting quality metrics to senior leadership.
• Added advantage: CQE/CQA, Lean manufacturing, Six Sigma green/black belt, GMP/ISO auditor.