About this role
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.