Quality Assurance Manager

Cure Talent; Stevenage; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Cure Talent are partnering with a specialist medical device manufacturer whose portable neonatal incubators are deployed in challenging environments across global markets. As Quality Manager, you will own the ISO 13485 QMS and lead quality across the business, based in Stevenage, Hertfordshire with two days per week working from home.

This role offers a defined growth path into regulatory affairs and potential PRRC responsibility as the business scales, with early involvement in MDR/Notified

Qualifications

• 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.
• CAPA management, non-conformance handling and document control experience.
• Working knowledge of the EU MDR; FDA QMSR experience is a plus.
• Interest in regulatory affairs and desire to grow into it.
• Practical, roll-your-sleeves-up mindset suited to a fast-moving SME.

Responsibilities

• Maintain, develop and improve the QMS in line with ISO 13485:2016 and medical device regs.
• Lead non-conformity management, CAPA, change control, document control and training.
• Plan and conduct internal, supplier and Notified Body audits.
• Manage supplier qualification, monitoring and performance reviews.
• Support batch release, traceability, complaint handling and post-market surveillance.
• Contribute to CE marking maintenance under MDR, CREs, PSURs and regulatory docs.
• Maintain awareness of regulatory changes and support broader regulatory strategy.

Skills

ISO 13485

QMS development

Internal audits

Supplier audits

CAPA management

Notified Body audits

Regulatory awareness

Regulatory affairs interest

Job description

Cure Talent are delighted to be partnered with a specialist medical device manufacturer whose portable neonatal incubators are deployed in some of the world's most challenging environments, from emergency responses in active conflict zones to hospitals across multiple international markets including the US and Australia. It is a business with a clear social purpose and serious commercial momentum, having grown sales by more than 10x year-on-year.

FDA-cleared and scaling fast, the team is small, pragmatic, and genuinely committed to the work they do. This is not a corporate quality role.

The Opportunity

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 in Stevenage, Hertfordshire with two days per week working from home, you will be expected to hit the ground running across a broad remit that includes:

• 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 comes with a defined pathway for growth. For the right person, there is a genuine opportunity to broaden into regulatory affairs and progress toward a senior regulatory leadership position, including potential PRRC responsibility, as the business continues to develop.

What We’re Looking For

• 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

Why This Role

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.