Quality Engineer – Medical Devices

Ref: 119

Job title: Quality Engineer – Medical Devices

Salary: £38,000 – £42,000

Location: Leeds

The role:
We are looking for an experienced and customer-focused Quality Engineer to join a growing Quality team within a regulated medical device manufacturing environment. The role will focus on quality assurance, customer relationships, complaint management and continuous improvement, ensuring manufacturing operations meet regulatory requirements, internal quality standards and customer expectations across Class I, II and III medical devices.

Key Responsibilities:

• Act as a key quality contact for customers, building strong professional relationships and ensuring quality-related issues are resolved effectively and promptly.
• Manage customer complaints from initial receipt through investigation, root cause analysis, corrective action and closure.
• Lead and support Non-Conformance (NC) investigations and CAPA activities in accordance with regulatory and Quality Management System requirements.
• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485, EU MDR, FDA and other applicable regulatory standards.
• Ensure ongoing compliance with Medical Device Regulation requirements across manufacturing and quality processes.
• Review, develop and improve quality procedures, work instructions and supporting documentation.
• Collaborate with Manufacturing and Engineering teams to drive continuous improvement and reduce quality issues.
• Participate in internal, customer and regulatory audits as required.
• Analyse quality data and trends to identify recurring issues and implement appropriate preventive actions.
• Support validation, inspection and manufacturing activities where required.
• Communicate quality performance, trends and issues effectively to internal stakeholders and customers.
• Promote and contribute to a strong quality culture throughout the organisation.

The Successful Candidate:

• A degree or equivalent qualification in Engineering, Quality, Manufacturing or a related technical discipline.
• Proven experience within a Quality Engineering or Quality Assurance role in the medical device industry.
• Strong understanding of medical device manufacturing environments, ideally involving Class I, II and III devices.
• Good working knowledge of ISO 13485, EU MDR, FDA regulations and relevant medical device compliance requirements.
• Hands-on experience managing customer complaints, Non-Conformances, CAPA systems, Root Cause Analysis and Quality Management Systems.
• Experience working within a regulated medical device manufacturing environment.
• Experience with inspection methodologies, metrology and Coordinate Measuring Machines (CMM).
• Experience supporting CNC machining and precision manufacturing operations.
• Strong problem-solving and analytical skills, with experience using RCA tools including 5 Whys, Fishbone/Ishikawa, Pareto Analysis, 8D and FMEA.
• Excellent communication, stakeholder management and customer-facing skills.
• The ability to work cross-functionally within a fast-paced manufacturing environment.
• Knowledge of statistical analysis and quality tools would be advantageous.
• Experience analysing manufacturing and quality data to identify trends and drive continuous improvement.
• Strong presentation and reporting skills, with the ability to communicate quality metrics and findings clearly.
• Experience supporting Lean manufacturing or Six Sigma continuous improvement initiatives would be beneficial.
• Lean Six Sigma certification or a relevant qualification would be desirable.
• Auditor qualifications or previous audit experience would be advantageous.
• Customer-focused, detail-oriented and proactive, with a solutions-driven approach.
• Strong organisational and prioritisation skills.
• A confident communicator capable of engaging effectively with customers and senior stakeholders.
• Able to work effectively both independently and as part of a wider team.