Assistant Manager - Quality Assurance - Medical Devices

Assistant Manager - Quality Assurance - Medical Devices

(Based at Unichela Panadura)

The Bodywear Value Stream of MAS Holdings delivers end-to-end design, innovation and manufacturing solutions across lingerie, swimwear and next-to-skin categories. It brings together broad expertise in fit, comfort, performance and aesthetics to serve leading global brands at scale.
With design and innovation hubs in Sri Lanka, the USA, Canada and Hong Kong and manufacturing operations across Sri Lanka, Bangladesh, India, Vietnam, Indonesia and Kenya, Bodywear offers a diverse portfolio spanning bras, briefs, shapewear, sleepwear, performance bodywear and Olympic grade swimwear. The value stream portfolio includes Victoria’s Secret, Calvin Klein, Marks & Spencer, Triumph, Speedo and Aerie. Positioned as a global centre of excellence, the Bodywear Value Stream combines advanced product innovation, technology-led solutions and operational scale to meet evolving consumer expectations across intimate and swim categories.

Empower transformation by becoming a driving force of change at MAS as we are on the lookout for a dedicated individual to join the team as an Assistant Manager - Quality Assurance - Medical Devices. This role will enable you to drive the QA function across the SBU Value Stream, whilst keeping to the Quality Engineering Principles within the BIQ Framework (about Product/Processes), driving product safety, robust craftsmanship excellence and Quality Systems Engineering in order to meet customer quality standards/ISO 9001/13485/GMP. Driving the respective sub pillars of SBU specific Strategic Projects in order to meet business requirements.

Key Responsibilities:

• To ensure and drive the implementation of international quality management systems (ISO 13485, GMP, and ISO 22716) for medical devices and other apparel.
• Optimise quality systems to deliver brand quality requirements.
• Mitigate risks through Product & Process FMEA (Process Failure Mode and Effects Analysis) and Hygiene FMEA to meet feminine hygiene and medical product requirements.
• Ensure the required solutions are implemented to deliver craftsmanship excellence by leveraging 1st 10 Pcs Audit, 1st 100 Pcs Audit, Inline Audit, End-line Audit, Pre-Final Audit, and Final Audit.
• Ensure proactive mould prevention to prevent colony growth in merchandise.
• Collaborate with international and local certification bodies and consultants to ensure the factory's internal audit function is aligned with ISO 13485, ISO 9001, and ISO 22716 through lead auditor certification.
• Critically analyse customer complaints and conduct problem-solving initiatives to deliver temporary and permanent countermeasures.
• Demonstrate robust traceability compliance through traceability audits and systematic DHR (Device History Records) maintenance.
• Facilitate agile capacity planning and ensure specific customer requirements are understood and translated to compatible subcontract plants through brand accreditation for partnered factories.
• Deploy BIQ (Built-in Quality) principles by acquiring Lean Belt qualifications and awareness, and echo VOC through setting standards, systematic problem-solving, systematic error-proofing, and implementation of a Kaizen mindset.
• Monitor and improve the Value Stream Quality Index.
• Collaborate with the division to roll out pockets of excellence.

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, Biomedical, Mechanical, Industrial, Manufacturing Engineering, or a related field.
• 5–8 years of experience in Quality Assurance, preferably in medical devices, pharmaceuticals, or other highly regulated manufacturing industries.
• Hands-on experience in medical device or highly regulated manufacturing environments.
• Proven experience managing internal, external, customer, and regulatory audits, including FDA and ISO certification audits.
• Experience in Supplier Quality Management, including supplier qualification, performance monitoring, and audits.
• Strong knowledge of ISO 13485 and ISO 9001.
• Lean Six Sigma Green Belt/Black Belt certification.
• Strong leadership, analytical, problem-solving, communication, and stakeholder management skills.