Quality Engineer

Do you have strong experience across ISO 13485, CAPA, non-conformance, customer complaints and root cause analysis, combined with the leadership skills to mentor and manage a small quality team?

We are recruiting for a Senior Quality Engineer to join a growing Quality Assurance function within a precision engineering and medical device manufacturing environment, supporting major OEM customers across Class I, II and III medical devices.

This is a senior, hands-on quality role with significant responsibility for customer relationships, quality investigations, regulatory compliance and continuous improvement, as well as providing day-to-day leadership, mentoring and support to a small team of quality professionals.

As Senior Quality Engineer, you will act as a key quality interface between the business, its customers and internal manufacturing and engineering teams.

Your responsibilities will include:

• Acting as a primary Quality interface for key OEM customers
• Building and maintaining strong customer relationships and ensuring timely resolution of quality issues
• Managing customer complaints from initial investigation through to root cause, corrective action and closure
• Leading Non-Conformance (NC) investigations and CAPA activities
• Supporting and maintaining the Quality Management System (QMS) in accordance with ISO 13485, EU MDR and FDA requirements
• Ensuring continued compliance with applicable medical device regulatory requirements
• Reviewing, developing and improving quality procedures, work instructions and documentation
• Working closely with Manufacturing and Engineering teams to drive continuous improvement
• Analysing quality data and trends to identify recurring issues and implement preventative actions
• Supporting internal, customer and regulatory audits
• Supporting validation, inspection and manufacturing activities
• Communicating quality performance, trends and issues to customers and senior stakeholders
• Promoting and embedding a strong quality culture
• Mentoring, coaching and providing day-to-day support to a small Quality team
• Helping to prioritise workload, develop team capability and maintain high standards across the Quality function

We are looking for an experienced Senior Quality Engineer / Senior Quality Assurance Engineer / Quality Engineer with proven experience within a regulated medical device manufacturing environment.

You will need:

• Proven experience in a Quality Engineering or Quality Assurance role within medical devices
• Strong understanding of medical device manufacturing, ideally across Class I, II and III devices
• Good knowledge of ISO 13485, EU MDR and FDA regulations
• Hands-on experience managing customer complaints, NCs, CAPA, RCA and QMS activities
• Strong experience with root cause analysis and problem solving, including 5 Whys, Fishbone/Ishikawa, Pareto, 8D and FMEA
• Experience working within a precision manufacturing / CNC machining environment
• Knowledge of inspection, metrology and CMM
• Experience using quality data and trends to drive corrective and preventative action
• Strong customer-facing and stakeholder management skills
• Excellent communication and presentation skills
• The ability to work effectively across Quality, Manufacturing and Engineering
• Previous experience mentoring, coaching or managing a small team within a Quality function – ESSENTIAL
• A degree or equivalent qualification in Engineering, Quality, Manufacturing or a related technical discipline

The following would be advantageous:

• Lean / Six Sigma experience or qualification
• Statistical analysis and quality tools
• Quality auditing experience or auditor qualification
• Experience supporting continuous improvement programmes
• Experience within advanced precision engineering and CNC manufacturing

This is an excellent opportunity for a Senior Quality Engineer to take a key role within a growing medical device manufacturing environment, working directly with leading global OEM customers.

You will gain exposure to advanced manufacturing, regulated medical device production, customer quality, regulatory compliance and continuous improvement, while also taking responsibility for developing and supporting a small Quality team.