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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 that make a difference 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