Job description
We are seeking a results-driven Quality Manager to lead and elevate ISO 13485 quality standards across the full product lifecycle in the medical devices sector. This role at Mills Recruitment (on behalf of our client) will require strategic QMS leadership, strong regulatory understanding, and a passion for continuous improvement. You will own quality strategy from product design through manufacturing, testing, release, and post-market support, ensuring compliance with international standards and local regulatory requirements.
As the Quality Manager, you will oversee a cross-functional team, coordinate internal and external audits, manage CAPA, deviations, change control, and document control. You will partner with engineering, manufacturing, regulatory, and supplier quality to drive risk management, process validation, supplier qualification, and quality metrics that inform business decisions. Your leadership will foster a culture of quality, safety, and reliability while maintaining efficient operations and a strong customer focus.
The ideal candidate will bring deep knowledge of ISO 13485, ISO 14971 risk management, GMP guidelines, and relevant regulatory expectations for medical devices. You will translate complex regulatory requirements into practical procedures and training, monitor supplier performance, and implement robust continuous improvement programs. If you are a proactive leader who thrives in a regulated manufacturing environment and is committed to delivering high-quality medical devices, we want to hear from you.
Responsibility
- Lead the development, deployment, and ongoing improvement of the Quality Management System (QMS) in line with ISO 13485 for all medical devices across the product lifecycle.
- Plan, conduct, and close internal audits; coordinate external audits; track non-conformances and CAPA to ensure sustained compliance.
- Own documentation control, policy and procedure updates, and change control processes to maintain traceability and compliance.
- Drive risk management per ISO 14971, perform risk assessments, implement mitigation strategies, and monitor residual risk.
- Manage supplier quality including supplier qualification, audits, performance monitoring, and CAPA collaboration to ensure component quality.
- Oversee product releases, process validation, and ongoing quality control during manufacturing to ensure defect-free, compliant products.
- Collaborate with R&D, Regulatory, and Manufacturing to ensure design transfer, validation, and regulatory readiness; support post-market surveillance and CAPA analysis.
Qualification
- Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, or related field. Master’s degree or relevant certifications are a plus.
- Minimum 5 years of quality management experience in medical devices or regulated manufacturing environments.
- ISO 13485 Lead Auditor certification preferred; additional certifications in Six Sigma/Lean are advantageous.
- Strong knowledge of ISO 13485, ISO 14971, GMP, and regulatory expectations from local authorities for medical devices.
- Experience with CAPA, non-conformances, change control, supplier quality management, and document control systems.
- Excellent leadership, communication, problem-solving, and data-driven decision-making skills; ability to lead cross-functional teams.