At a Glance
- Tasks: Lead quality assurance and improve ISO 13485 QMS in a dynamic medical device company.
- Company: Innovative medical device manufacturer with a strong social purpose.
- Benefits: Flexible working, career growth opportunities, and a chance to make a real impact.
- Other info: Opportunity to progress into regulatory affairs and senior leadership roles.
- Why this job: Join a passionate team making a difference in neonatal care worldwide.
- Qualifications: Experience in quality management within the medical device industry is essential.
The predicted salary is between 45000 - 55000 £ per year.
While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required. 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 Assurance 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-conformity management
Quality Manager employer: Cure Talent
Join a leading global medical device company that is dedicated to innovation and excellence in life-saving technologies. As a Senior Regulatory Affairs Specialist, you will thrive in a collaborative work culture that values mentorship and continuous improvement, while enjoying opportunities for professional growth in a dynamic environment. Located in a vibrant area, this role offers the chance to make a meaningful impact on product portfolios and regulatory strategies, ensuring your contributions are recognised and valued.
