Quality Control Manager (Medical Devices)

About the role

The Wearables and Growth Platforms team is building the next generation of medical‑device garments. We are looking for a senior professional to lead quality control across development and manufacturing of soft‑goods, ensuring compliance with global regulatory standards.

Key responsibilities

• Establish, implement and maintain quality system processes aligned with ISO 13485, GLP and GMP.
• Ensure compliance with ISO 14971 risk‑management and regional regulations (US FDA, EU MDR, TGA, etc.).
• Own regulatory audit readiness and act as primary contact during external and internal audits.
• Lead quality risk‑management activities throughout the product lifecycle.
• Develop, implement and maintain quality control plans, including documentation review and approval.
• Design, verify and validate test methodologies for textile‑based medical device garments.
• Drive quality involvement in new‑product integration and design transfer to manufacturing.
• Manage supplier quality programmes and act as the main liaison with contract manufacturers.
• Lead root‑cause analysis, CAPA and change‑control processes.
• Motivate and manage a cross‑functional quality team and report performance to leadership.

Required profile

• BEng/BSc/BTec or equivalent technical degree with a minor in management.
• Hands‑on experience implementing GLP/GMP and ISO 13485 quality systems in medical‑device development or manufacturing.
• Proven people‑management experience leading technical or manufacturing teams.
• Solid background in materials, textiles or garment development, testing and quality control.
• Demonstrated capability in quality risk management, QC planning, documentation control and supplier quality.
• Experience with audits, CAPA, change control and reporting quality metrics to senior leadership.

Required skills

• ISO 13485
• ISO 14971 risk management
• GLP and GMP compliance
• Six Sigma (green/black belt)
• Lean manufacturing
• CQE/CQA
• Quality control test method development and validation
• Design transfer and new‑product introduction
• Supplier quality management
• Root‑cause analysis and CAPA
• Change control processes
• Quality metrics reporting