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For Companies At a Glance
- Tasks: Drive quality improvements and lead projects in a dynamic medical device environment.
- Company: Join a world-leading medical device manufacturer with a focus on innovation.
- Benefits: Enjoy hybrid working, career progression, and a collaborative culture.
- Why this job: Make a real impact on patient outcomes while influencing quality strategy.
- Qualifications: Experience in medical devices and strong knowledge of ISO 13485 required.
- Other info: Great opportunity for growth in a high-visibility role.
The predicted salary is between 36000 - 60000 £ per year.
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.
Senior Quality Engineer in Selby employer: Cypartners
Contact Detail:
Cypartners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Engineer in Selby
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical devices field and let them know you're on the hunt for a Senior Quality Engineer role. You never know who might have the inside scoop on openings or can put in a good word for you.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of ISO 13485 and CAPA processes. We recommend creating a list of potential questions and practicing your answers. This will help you feel confident and ready to showcase your expertise!
✨Tip Number 3
Don’t forget to highlight your leadership skills! When discussing your experience, focus on how you've mentored teams or led projects. This is key for a role that involves influencing quality strategy and driving improvements.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're serious about joining a company that values quality and continuous improvement.
We think you need these skills to ace Senior Quality Engineer in Selby
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the Senior Quality Engineer role. Highlight your experience with ISO 13485 and any relevant projects you've led. We want to see how your background aligns with the key responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality engineering in medical devices. Share specific examples of how you've driven improvements and influenced quality strategy in your previous roles, as this will resonate with us.
Showcase Your Skills: Don’t forget to highlight your communication and stakeholder engagement skills. We’re looking for someone who can lead and mentor effectively, so give us examples of how you’ve done this in the past. It’s all about demonstrating your ability to manage multiple projects while maintaining high-quality standards.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. This way, we can easily track your application and ensure it gets the attention it deserves. Plus, it shows us you’re keen on joining our team!
How to prepare for a job interview at Cypartners
✨Know Your Standards
Familiarise yourself with ISO 13485:2016 and other relevant regulatory frameworks. Be ready to discuss how you've maintained compliance in previous roles, as this will show your understanding of the standards expected in the medical device industry.
✨Showcase Your Leadership Skills
Prepare examples of how you've led projects or mentored teams in the past. Highlight your ability to influence quality strategy and drive improvements, as this role requires strong leadership within the QC function.
✨Be Ready for Technical Questions
Expect questions about CAPA management and change control processes. Brush up on your knowledge of the full CAPA lifecycle and be prepared to discuss specific instances where you’ve successfully managed these processes.
✨Engage with Stakeholders
Demonstrate your excellent communication skills by preparing to discuss how you've engaged with various stakeholders in previous roles. Think of examples where you escalated risks or recommended improvements during Quality Review Meetings.
