On-site Quality Engineer - Medical Devices (ISO 13485/CAPA)

Cameron Clarke Associates t/a talent-finder; Leeds; Vor Ort; GBP 41.000 - 50.000; Vollzeit

Zusammenfassung

Cameron Clarke Associates t/a talent-finder in Leeds seeks a hands-on Quality Engineer for a medical devices environment. You will own the QMS, ensure ISO 13485 alignment, and support UKCA/CE/MDR requirements while collaborating with manufacturing and cross-functional teams to maintain high product quality.

The role offers visibility, real ownership, and scope to drive continuous improvement in a small but growing medical devices company. Prior medical devices experience is essential.

Qualifikationen

• Experience in medical devices quality systems and ISO 13485.
• Strong knowledge of QMS processes: CAPA, document control, change control, deviations, NCRs.
• Experience supporting or leading internal/external audits.
• Familiar with MDR/UK MDR and UKCA requirements.
• Degree in science/engineering or related discipline.

Aufgaben

• 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 compliance activities and technical documentation.
• Lead and support investigations into non-conformances, complaints and quality issues.
• Carry out root cause analysis and implement CAPA.
• Support internal and external audits, including preparation and follow-up actions.
• Monitor quality data and trends to identify risks and drive improvement.
• Support supplier approval and ongoing quality performance.
• Assist with validation activities and production quality verification where required.
• Work closely with manufacturing and cross-functional teams to ensure product quality.
• Support the QA/RA Director with departmental workload and priorities.
• Contribute to a proactive, improvement-led quality culture.

Kenntnisse

Medical Devices

ISO 13485

CAPA

Document control

Change control

Deviations

NCRs

Audits

MDR

UK MDR

UKCA

Root cause analysis

Quality investigations

Right to work

Ausbildung

Bachelor's degree in science/engineering

Jobbeschreibung

Cameron Clarke Associates t/a talent-finder in Leeds seeks a hands-on Quality Engineer for a medical devices environment. You will own the QMS, ensure ISO 13485 alignment, and support UKCA/CE/MDR requirements while collaborating with manufacturing and cross-functional teams to maintain high product quality.

The role offers visibility, real ownership, and scope to drive continuous improvement in a small but growing medical devices company. Prior medical devices experience is essential.