Senior Quality Engineer

Cypartners; Selby; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

A leading Medical Device manufacturer seeks a Senior Quality Engineer to join their UK Quality team. This role focuses on regulatory compliance and operational excellence, managing CAPA, change control, and QMS activities. The ideal candidate has experience in medical device manufacturing, strong knowledge of ISO 13485, and excellent communication skills. This position offers hybrid working, career progression, and a collaborative culture focused on quality. Full right to work in the UK is required.

Benefits

Hybrid working for improved work-life balance

Role with ownership and strategic input

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

Senior Quality Engineer – Medical Devices (Permanent | Hybrid Working)

CY Partners are supporting a world-leading Medical Device manufacturer in the appointment of a Senior Quality Engineer to join their UK Quality function. This is a high-visibility role at the centre of regulatory compliance and operational excellence, ideal for someone who enjoys driving improvements, leading projects and influencing Quality strategy.

Working on products to patient outcomes globally, you’ll take ownership of CAPA, change control and QMS activity, whilst maintaining standards across multiple regulatory frameworks. With hybrid working and room to grow, this is a great opportunity for an experienced Quality professional to step into a role with influence and impact.

Key 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

About you

Education & Qualification

• HNC or equivalent minimum
• ISO 13485 Internal Auditor certification preferred

Experience

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

Skills & Competencies

• 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

What’s on offer

• Hybrid working for improved work-life balance
• Role with ownership, visibility and strategic input
• Career progression and development opportunities
• Collaborative culture focused on quality and continuous improvement

This role is being managed confidentially by CY Partners. For full details, please contact Dan Younger, or apply for a confidential conversation.

Applicants must have full and current Right to Work in the UK. CY Partners is acting as an employment agency in relation to this position.