Head of Quality & Continuous Improvement

Elevation Recruitment Group are exclusively partnered with a leading medical devices manufacturer in Leeds who are seeking a driven and experienced Head of Quality & Continuous Improvement to lead their Quality and Compliance functions across the UK and international operations. You will ensure their products meet all necessary regulatory and quality standards, support continuous improvement, and drive business efficiency.

In this pivotal role, you’ll oversee ISO9001, ISO13485, MDR 2017/745, and FDA 21 CFR 820 compliance, lead internal and external audits, and work cross-functionally to support product development, supplier quality, and lean manufacturing practices. You’ll also guide a dedicated team, influence senior leadership, and ensure regulatory readiness across the businesses portfolio.Key Duties & Responsibilities:

• Lead the Quality and Regulatory teams, providing strategic direction, training, and motivation

• Ensure compliance with all relevant international standards and regulations (MDR, ISO13485, FDA)

• Oversee internal/external audits, QMS development, and non-conformance management

• Collaborate with supply chain and R&D to embed quality into new and existing products

• Drive lean initiatives and cost-saving projects including COPQ and NCR reductions

• Act as the primary Quality representative at board-level and external meetings

• Develop business reporting to track performance, compliance, and continuous improvement

• Maintain strong relationships with external bodies and represent the business in regulatory mattersI'm keen to speak to Head's of Quality or Quality Manager's with the following skillset:

  • Lead Auditor for ISO9001 and ISO13485

  • Strong knowledge of MDD, MDR, FDA, and ISO standards

  • Proven leadership in quality & regulatory roles within engineering, medical, or manufacturing sectors

  • Lean Six Sigma Green Belt (minimum)

  • Experience managing compliance, supplier quality, and product lifecycle documentation