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- Tasks: Join the Innovation team as a Design Quality Engineer, ensuring product compliance and quality.
- Company: Exciting British Medical Device Manufacturer focused on innovative technologies and growth.
- Benefits: Enjoy a hybrid work model with 3 days on-site and opportunities for professional development.
- Why this job: Be part of a dynamic team driving impactful medical innovations and improving lives.
- Qualifications: Degree in Engineering or Life Sciences; proven experience in Quality Assurance within Medical Devices.
- Other info: Collaborate with cross-functional teams and contribute to the full product lifecycle.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with an exciting, British Medical Device Manufacturer who, due to continued growth and investment, have an exciting opportunity for a Design Quality Engineer to join their Innovation team. This is a hybrid role (3 days on-site per week) based at their site in Bracknell, offering the opportunity to support the full product lifecycle of innovative medical technologies.
As their new Design Quality Engineer, you will be responsible for ensuring compliance with ISO 13485, ISO 14971, FDA QSR, and other relevant regulatory standards throughout the development and post-market phases. You will work closely with cross-functional teams across engineering, manufacturing, regulatory and supply chain to drive product and process quality from concept to commercialisation.
To be successful in this role, we are looking for an experienced Quality Assurance professional with proven Medical Device experience. You will have demonstrable experience of design control activities, including management of DHF and DMR.
Key Responsibilities:- Provide quality support for product design, change control, and technical documentation.
- Review and approve engineering drawings, electronic schematics, specifications, and verification plans.
- Support compliance with ISO 13485, ISO 14971, FDA design control, and other regulatory standards.
- Lead or participate in product risk assessments and maintain associated documentation.
- Contribute to QMS development and improvement, including Design History Files and Device Master Records.
- Analyse complaint and field data to identify trends and drive CAPA activities.
- A degree in Engineering, Life Sciences, or a related technical field (or equivalent experience).
- Proven Quality Assurance experience within Medical Devices.
- Demonstrable experience of Design Control Activities, DMR and DHF management.
- Knowledge of ISO 13485, ISO 14971, FDA QSR, and design control principles.
- Familiarity with reviewing engineering documentation and technical drawings.
If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today!
Design Quality Engineer employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Quality Engineer
✨Tip Number 1
Familiarise yourself with the specific ISO standards mentioned in the job description, such as ISO 13485 and ISO 14971. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device sector.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in design quality engineering. Attend relevant webinars or local meetups to gain insights and potentially get referrals that could help you land the job.
✨Tip Number 3
Prepare to discuss specific examples from your past work where you successfully managed design control activities or contributed to compliance with regulatory standards. Real-life scenarios can make a strong impression during interviews.
✨Tip Number 4
Research the company’s recent projects and innovations in medical technology. Being knowledgeable about their products and initiatives will show your genuine interest in the role and help you stand out during the interview process.
We think you need these skills to ace Design Quality Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Design Quality Engineer position. Familiarise yourself with ISO 13485, ISO 14971, and FDA QSR standards as these are crucial for the role.
Tailor Your CV: Customise your CV to highlight your relevant experience in Quality Assurance within the Medical Device sector. Emphasise your knowledge of design control activities, DHF, and DMR management to align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and medical devices. Mention specific examples of how you've contributed to product quality and compliance in previous roles, particularly in relation to the key responsibilities listed.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is vital for this role.
How to prepare for a job interview at Cure Talent
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and FDA QSR regulations. 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 experience with design control activities, particularly in managing Design History Files (DHF) and Device Master Records (DMR). Prepare specific examples of projects where you contributed to product quality from concept to commercialisation.
✨Cross-Functional Collaboration
Emphasise your ability to work with cross-functional teams. Share examples of how you've collaborated with engineering, manufacturing, and regulatory teams to drive product quality and compliance, showcasing your teamwork skills.
✨Prepare for Risk Assessment Questions
Be ready to discuss your experience with product risk assessments. Think of instances where you led or participated in these assessments and how you maintained associated documentation, as this is a key responsibility of the role.
