Senior Quality Engineer - Medical Devices | Hybrid Impact

Cypartners; Selby; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading Medical Device manufacturer in the UK is seeking a Senior Quality Engineer to maintain compliance with ISO standards and manage CAPA processes. The role involves significant influence on Quality strategy, internal audits, and supplier quality agreements. Candidates should have a background in medical devices and ISO 13485 knowledge. This position offers hybrid working, career progression, and opportunities for strategic input in a collaborative culture focused on quality and improvement.

Benefits

Hybrid working for improved work-life balance

Career progression and development opportunities

Collaborative culture focused on quality and continuous improvement

Qualifications

• Background in Medical Devices or similarly regulated manufacturing.
• Strong working knowledge of ISO 13485 QMS frameworks.

Responsibilities

• Maintain and ensure compliance to ISO 13485:2016.
• Lead internal audits across ISO 13485, 21 CFR, MDR and UKCA.
• Manage the full CAPA lifecycle including investigation and timely closure.
• Lead and mentor the QC function, ensuring product release and high Quality standards.
• Own and manage Change Control processes with robust documentation.
• Deliver trend analysis for Quality Review Meetings, escalating risks and recommending improvements.
• Implement harmonised QMS documentation and compliant processes across business units.
• Review and manage supplier Quality Agreements.
• Act as a key Quality representative to senior leadership on regulatory readiness and continuous improvement.

Skills

Excellent communication and stakeholder engagement skills

Strong attention to detail and documentation accuracy

Organised, able to manage multiple projects simultaneously

Proactive, adaptable and able to influence change

Education

HNC or equivalent minimum

ISO 13485 Internal Auditor certification preferred

Job description

A leading Medical Device manufacturer in the UK is seeking a Senior Quality Engineer to maintain compliance with ISO standards and manage CAPA processes. The role involves significant influence on Quality strategy, internal audits, and supplier quality agreements. Candidates should have a background in medical devices and ISO 13485 knowledge. This position offers hybrid working, career progression, and opportunities for strategic input in a collaborative culture focused on quality and improvement.