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- Tasks: Support product development and ensure compliance with global quality standards.
- Company: Join a leading medical device company making a difference in healthcare.
- Benefits: Enjoy a hybrid work model and competitive salary with additional perks.
- Why this job: Be part of innovative projects that impact lives while working in a collaborative environment.
- Qualifications: Degree in Engineering or Life Sciences with 5+ years in medical device quality.
- Other info: Opportunity to obtain ASQ CQE certification if not already held.
The predicted salary is between 36000 - 60000 £ per year.
Senior Quality Engineer – Medical Devices Hybrid | South East / Home Counties | Circa £60,000 + Benefits A leading medical device company is seeking a Senior Quality Engineer to support product development and change control activities. This role will ensure compliance with global standards including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR. You\’ll act as the Quality representative across cross-functional teams, applying expertise in risk management, design controls, and CAPA to drive product and process quality from concept to launch. Key Requirements: Degree in Engineering or Life Sciences 5+ years\’ experience in Quality within medical devices Strong knowledge of ISO 13485, ISO 14971, FDA QSRs ASQ CQE preferred or willingness to obtain This is a great opportunity for an experienced Quality Engineer to contribute to meaningful product innovation in a collaborative, growth-focused environment. Apply now for more details
Snr Design Quality Engineer employer: Roc Search Europe Limited
Contact Detail:
Roc Search Europe Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Snr Design Quality Engineer
✨Tip Number 1
Network with professionals in the medical device industry. Attend relevant conferences or webinars where you can meet people who work in quality engineering roles. This can help you gain insights into the company culture and potentially get a referral.
✨Tip Number 2
Familiarise yourself with the latest trends and regulations in medical device quality assurance. Being knowledgeable about ISO standards and FDA regulations will not only boost your confidence but also demonstrate your commitment to the field during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've applied risk management and design controls in your previous roles. Having concrete stories ready will showcase your expertise and problem-solving skills, making you a more attractive candidate.
✨Tip Number 4
Research the company’s recent projects and innovations in medical devices. Understanding their product line and challenges they face will allow you to tailor your conversation and show how you can contribute to their goals.
We think you need these skills to ace Snr Design Quality Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and requirements. Highlight your relevant experience in quality engineering, particularly in medical devices, to align with what the company is looking for.
Tailor Your CV: Customise your CV to reflect your experience with ISO standards, risk management, and design controls. Use specific examples from your past roles that demonstrate your expertise and achievements in these areas.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality engineering and your understanding of the medical device industry. Mention how your skills can contribute to product innovation and compliance with global standards.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. Ensure that your application is clear, concise, and professional to make a strong impression.
How to prepare for a job interview at Roc Search Europe Limited
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and FDA QSRs. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise and understanding of compliance in the medical device industry.
✨Showcase Your Experience
Highlight your 5+ years of experience in quality within medical devices. Prepare specific examples of projects where you contributed to product development and change control activities, focusing on your role in ensuring product and process quality.
✨Emphasise Cross-Functional Collaboration
As a Quality representative, you'll work with various teams. Be ready to share examples of how you've successfully collaborated with cross-functional teams in the past, showcasing your ability to drive quality from concept to launch.
✨Prepare for Risk Management Questions
Expect questions about risk management and design controls. Brush up on your knowledge of CAPA processes and be ready to discuss how you've identified and mitigated risks in previous projects, as this is crucial for the role.
