Job Description
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