Design Quality Lead – 12 Month FTC
A leading global medical device organisation is seeking an experienced Design Quality Lead to join their team on a 12 month fixed-term contract. This is a key leadership role supporting new product development and ensuring the highest standards of quality and regulatory compliance across innovative healthcare solutions.
You will lead the Design Quality function, driving quality strategy across NPD and NPI activities while managing a team of Quality Engineers. This role offers strong visibility and the opportunity to make an immediate impact across critical projects.
Key responsibilities:
- Lead and develop a team of Quality Engineers, including performance management and resource planning
- Ensure compliance with ISO 13485, ISO 14971, MDR, FDA and related standards
- Oversee risk management activities and maintain product risk files
- Support validation activities including process, equipment and test methods
- Collaborate with R&D and Engineering to deliver robust product launches
- Lead audit readiness and support regulatory submissions
Requirements:
- Degree in Engineering, Science or related discipline
- 5+ years’ experience in medical devices, with 3+ years in a leadership role
- Strong knowledge of quality systems and regulatory frameworks
- Proven experience in NPD, validation and risk management
- Excellent leadership, communication and problem-solving skills
This is an excellent opportunity for a quality professional available for an initial 12 month contract, with exposure to a global organisation and cutting-edge product development.
For a confidential discussion, contact Kerry directly.
