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