Quality Manager

Cure Talent are partnered with a specialist medical device manufacturer whose portable neonatal incubators are deployed in challenging environments, from emergency responses in active conflict zones to hospitals across international markets including the US and Australia. The business has a clear social purpose and strong commercial momentum, with sales growing by more than 10x year-on-year. FDA-cleared and scaling fast, the team is small, pragmatic, and committed to their work.

About the role

As Quality Manager, you will take full ownership of the ISO 13485 QMS and lead quality activity across the business. Working closely with the leadership team and based primarily on-site in Stevenage, Hertfordshire (with one day per week working from home), you will hit the ground running across a broad remit:

• Maintaining, developing, and continuously improving the QMS in line with ISO 13485:2016 and applicable medical device regulations
• Leading non-conformity management, CAPA, change control, document control, and training processes
• Planning and conducting internal, supplier, and Notified Body audits
• Managing supplier qualification, monitoring, and performance reviews
• Supporting batch release, traceability, complaint handling, and post-market surveillance activities
• Contributing to CE marking maintenance under the MDR, Clinical Evaluation Reports, PSURs, and wider regulatory documentation
• Maintaining awareness of regulatory changes and supporting the company’s broader regulatory strategy

This role offers a defined pathway for growth. For the right candidate, there is an opportunity to broaden into regulatory affairs and progress toward a senior regulatory leadership position, including potential PRRC responsibility, as the business continues to develop.

Requirements

• Proven quality management experience within the medical device industry
• Strong ISO 13485 knowledge, including hands-on QMS development and maintenance
• Experience planning and conducting internal and supplier audits, with exposure to Notified Body audits
• A solid grasp of CAPA management, non-conformance handling, and document control
• Working knowledge of the EU MDR, with FDA QMSR experience a plus
• An interest in regulatory affairs and the ambition to grow into it
• A practical, roll-your-sleeves-up mindset suited to a fast-moving SME

Benefits

A rare chance to join a mission-led MedTech business at a pivotal point in its growth, with genuine ownership of quality operations from day one and a clear pathway toward senior regulatory responsibility.

Pay

£50,000 to £60,000

Job ref: CT2036 | Posted: 08-07-2026