Job description
As a Manager- Quality Control, you will be required to:
Establish, implement, and maintain quality system processes aligned with ISO 13485 and GLP/GMP standards across product development and manufacturing.
Ensure ongoing compliance with ISO 14971 (risk management for medical devices) and regional regulatory requirements (US FDA, EU MDR, TGA, and others as applicable).
Own regulatory audit readiness and act as a key point of contact during external/internal audits.
Lead quality risk management activities 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 appropriate to soft goods/textile-based medical device garments.
Drive quality control involvement in new product integration, ensuring quality requirements are embedded early in development.
Lead design transfer planning from development into manufacturing, ensuring a smooth, compliant handover.
Manage supplier quality activities, including establishing quality control touchpoints across the supply chain.
Serve as the primary quality liaison with contract manufacturers, ensuring their processes meet required quality and regulatory standards.
Lead root cause analysis for quality issues and non-conformances.
Manage change control processes and drive Corrective and Preventive Actions (CAPA).
Establish effective ongoing monitoring and control mechanisms to sustain quality performance.
Lead, manage, and motivate a cross-functional and multidisciplinary quality team.
Deliver against agreed targets and communicate progress/results clearly to leadership.
The ideal candidate should have:
A BEng, BSc, BTec, or equivalent technical degree with a minor in management studies
Experience in CQE/CQA, Lean manufacturing practices, Six Sigma- green/ black belt, GMP/ ISO auditor would be an added advantage
Solid background in materials, textiles, or garment development, manufacturing, and quality control/testing.
Proven people management experience, having led teams in a technical or manufacturing setting.
Hands-on experience implementing GLP/GMP and ISO 13485 quality systems, ideally within medical devices or healthcare product development/manufacturing.
Demonstrated capability in quality risk management, QC planning and execution, and documentation control.
Experience developing and validating QC test methods.
Direct involvement in new product introduction and design transfer processes.
Track record managing supplier quality programs and contract manufacturer relationships.
Strong problem-solving background: root cause analysis, CAPA, and change control.
Experience building and reporting quality metrics to senior leadership.