Quality Engineer - Medical Devices

Talent Finder; Leeds; Hybrid; GBP 41,000 - 50,000; Full time

Benefits offered by this job

HealthShield Classic health cash plan

Flexible home-working occasional

Job summary

Talent Finder seeks a Quality Engineer for a medical devices manufacturer in Leeds. You will own the QMS, drive ISO 13485 compliance, and support UKCA/CE/MDR regulatory activities in a hands-on, collaborative environment.

The role emphasizes CAPA, document control, audit prep, and continuous improvement across manufacturing, with visibility and real ownership in a small growing team.

Qualifications

• Proven experience in the Medical Devices industry and quality role.
• Strong knowledge of ISO 13485 and QMS.
• Around 5 years’ experience in a quality-related role.
• Experience with CAPA, document control, change control, deviations and NCRs.
• Experience supporting or leading internal and external audits.
• Understanding of UK MDR, EU MDR/CE and UKCA.
• Root cause analysis and quality investigations.
• Degree in a scientific, engineering or related discipline, or equivalent experience.
• UK-based with existing right to work (sponsorship not preferred).

Responsibilities

• Own and maintain the QMS in line with ISO 13485.
• Ensure quality processes and documentation remain compliant and effective.
• Support UKCA, CE and MDR regulatory activities and technical documentation.
• Lead investigations into non-conformances, complaints and quality issues.
• Carry out root cause analysis and implement CAPA.
• Support audits and coordinate with internal and external teams.
• Monitor quality data and drive continuous improvement.
• Collaborate with manufacturing and cross-functional teams.

Skills

Quality management

ISO 13485

CAPA

Audits

Root cause analysis

Education

Science/Engineering degree

Job description

Quality Engineer – Medical Devices | Leeds | Full Time | On-site (with occasional flexibility) | Up to £45,000 (DOE)

This is a hands-on Quality Engineer role within a specialist UK medical device manufacturer, where quality, compliance, and patient safety are central to everything the business does. You'll be joining a close-knit Quality & Regulatory team within a small but growing organisation of around 40 employees, working alongside experienced quality professionals and with support from a QA/RA leadership structure. The environment is collaborative and highly involved, with strong exposure to both manufacturing operations and quality system ownership.

The role sits at the heart of maintaining and continuously improving a well-established Quality Management System (QMS), with a strong focus on ISO 13485 compliance and ongoing adherence to UKCA and CE marking requirements. You'll take ownership of day-to-day quality activities including document control, non-conformance management, CAPA, and audit preparation, while also supporting both internal and external audits. Alongside this, you'll contribute to continuous improvement initiatives and help strengthen quality processes across the business.

This position is best suited to someone with direct medical device industry experience who is confident working within a regulated manufacturing environment. Given the size of the organisation, this is a highly visible role where you'll be trusted with real ownership and the opportunity to make a tangible impact. The business is also open to considering strong mid-level candidates who are looking to further develop within a supportive medical devices environment.

What will your role look like?

• Owning and maintaining the Quality Management System (QMS) in line with ISO 13485
• Ensuring quality processes, procedures and documentation remain compliant and effective
• Supporting UKCA, CE and MDR regulatory compliance activities and technical documentation
• Leading and supporting investigations into non-conformances, complaints and quality issues
• Carrying out root cause analysis and implementing effective corrective and preventive actions (CAPA)
• Supporting internal and external audits, including preparation, participation and follow-up actions
• Monitoring quality data and trends to identify risks and drive continuous improvement
• Supporting supplier approval, monitoring and ongoing quality performance
• Assisting with validation activities and production quality verification where required
• Working closely with manufacturing and cross-functional teams to ensure product quality is maintained
• Supporting the QA/RA Director with departmental workload and compliance priorities
• Contributing to a proactive, improvement-led quality culture across the business

Are you the right person for the job?

• Proven experience within the Medical Devices industry (essential)
• Strong working knowledge of ISO 13485 and Quality Management Systems
• Around 5 years’ experience in a quality-related role (flexible for the right candidate)
• Confident working with QMS processes such as CAPA, document control, change control, deviations and NCRs
• Experience supporting or leading internal and external audits
• Understanding of regulatory frameworks including UK MDR, EU MDR/CE and UKCA
• Experience in root cause analysis and quality investigations
• Degree in a scientific, engineering or related discipline (or equivalent experience)
• UK-based with existing right to work (sponsorship not preferred)

What’s in it for you?

• Opportunity to work in a true Medical Devices environment with full exposure to ISO 13485 systems
• Small, collaborative team where your input directly shapes quality processes and compliance standards
• Hands-on role with visibility across manufacturing, quality systems, and regulatory activity
• HealthShield Classic health cash plan (post-probation) supporting dental, optical and wellbeing costs
• Stable working environment with a strong focus on quality and continuous improvement
• Occasional ad hoc flexibility to work from home where appropriate

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