Manager- Quality Control

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.