At a Glance
- Tasks: Lead quality and compliance teams, ensuring regulatory readiness and driving continuous improvement.
- Company: Join a leading medical devices manufacturer in Leeds, known for innovation and excellence.
- Benefits: Enjoy a senior leadership role with opportunities for professional growth and impactful work.
- Why this job: Be at the forefront of quality in medical devices, influencing product innovation and operational efficiency.
- Qualifications: Must have Lead Auditor certification and proven leadership experience in regulated environments.
- Other info: Ideal for those passionate about quality and compliance in the medical sector.
The predicted salary is between 54000 - 84000 £ per year.
Elevation Recruitment Group is exclusively partnered with a leading medical devices manufacturer in Leeds in the search for a dynamic and experienced Head of Quality & Continuous Improvement. This is a senior, business-critical role—ideal for someone with a proven background in quality leadership within regulated environments such as medical devices.
You’ll lead Quality and Compliance functions across both UK and international operations, ensuring regulatory readiness, driving continuous improvement, and supporting product innovation and operational efficiency.
Location: Leeds
Sector: Medical Devices / Manufacturing
Level: Senior Leadership
Key Responsibilities:
- Lead and develop the Quality & Regulatory teams across the business
- Ensure full compliance with ISO 9001, ISO 13485, MDR 2017/745, and FDA 21 CFR 820
- Oversee internal/external audits, QMS improvements, and non-conformance processes
- Collaborate with R&D and Supply Chain to embed quality into all stages of product development
- Champion Lean initiatives, cost reduction projects (COPQ, NCR), and continuous improvement
- Act as the key Quality representative at board and external regulatory meetings
- Maintain reporting and KPIs to track compliance and quality performance
We’re looking for:
- Lead Auditor certification for ISO 9001 & ISO 13485
- Strong knowledge of MDD, MDR, FDA, and ISO regulatory frameworks
- Proven leadership experience in quality & regulatory roles (medical, engineering, or manufacturing)
- Lean Six Sigma Green Belt (minimum)
- Experience with supplier quality, QMS, and product lifecycle documentation
Head of Quality & Continuous Improvement employer: Elevation Recruitment Group
Contact Detail:
Elevation Recruitment Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Quality & Continuous Improvement
✨Tip Number 1
Network with professionals in the medical devices sector, especially those who have experience in quality leadership roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in quality management.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks mentioned in the job description, such as ISO 9001, ISO 13485, and FDA regulations. Being able to discuss these in detail during interviews will demonstrate your expertise and commitment to compliance.
✨Tip Number 3
Prepare examples of how you've successfully led quality improvement initiatives in previous roles. Highlight your experience with Lean Six Sigma methodologies and how they contributed to operational efficiency and cost reduction.
✨Tip Number 4
Research the company’s current quality practices and any recent news related to their products or compliance issues. This knowledge will help you tailor your discussions and show that you're genuinely interested in contributing to their success.
We think you need these skills to ace Head of Quality & Continuous Improvement
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality leadership, particularly within regulated environments like medical devices. Emphasise your certifications, such as Lead Auditor for ISO 9001 and ISO 13485, and any relevant Lean Six Sigma qualifications.
Craft a Compelling Cover Letter: In your cover letter, demonstrate your understanding of the key responsibilities outlined in the job description. Discuss how your previous roles have prepared you to lead Quality and Compliance functions and drive continuous improvement.
Highlight Relevant Achievements: When detailing your work experience, focus on specific achievements that showcase your ability to ensure compliance with regulatory frameworks like MDR and FDA. Use metrics where possible to illustrate your impact on quality performance and operational efficiency.
Showcase Leadership Skills: Since this is a senior leadership role, be sure to highlight your leadership experience. Discuss how you've developed teams, led audits, and collaborated with other departments to embed quality into product development.
How to prepare for a job interview at Elevation Recruitment Group
✨Showcase Your Leadership Experience
As a Head of Quality & Continuous Improvement, your leadership skills are crucial. Be prepared to discuss specific examples of how you've led teams in quality and regulatory roles, particularly in regulated environments like medical devices.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with ISO 9001, ISO 13485, MDR 2017/745, and FDA 21 CFR 820. During the interview, highlight your experience with these standards and how you've ensured compliance in previous roles.
✨Emphasise Continuous Improvement Initiatives
Discuss your experience with Lean initiatives and continuous improvement projects. Be ready to provide examples of how you've driven efficiency and cost reduction in past positions, showcasing your ability to champion change.
✨Prepare for Technical Questions
Expect technical questions related to quality management systems and audits. Brush up on your knowledge of QMS improvements and non-conformance processes, as well as how you would approach internal and external audits.