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- Tasks: Join the Innovation team as a Design Quality Engineer, ensuring product compliance and quality.
- Company: Cure Talent partners with a leading British Medical Device Manufacturer focused on innovation.
- Benefits: Enjoy a hybrid work model with three days on-site and opportunities for professional growth.
- Why this job: Be part of a dynamic team driving medical technology from concept to market with real impact.
- 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 quality management system improvements.
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.
- 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!
Quality and Design Engineer employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Design Engineer
✨Tip Number 1
Familiarise yourself with the specific regulatory standards mentioned in the job description, such as ISO 13485 and FDA QSR. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality assurance roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with design control activities and managing DHF and DMR. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Research the company’s recent projects or innovations in medical technology. Showing that you are informed about their work can help you make a strong impression and demonstrate your genuine interest in the role.
We think you need these skills to ace Quality and Design Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and requirements for the Quality and Design Engineer position. Tailor your application to highlight how your experience aligns with these specific needs.
Highlight Relevant Experience: Emphasise your experience in Quality Assurance within the Medical Device sector. Provide specific examples of your work with ISO 13485, ISO 14971, and FDA QSR compliance, as well as your involvement in design control activities.
Showcase Technical Skills: Mention your familiarity with engineering documentation, technical drawings, and risk assessments. Detail any relevant projects where you contributed to product quality and compliance, showcasing your technical expertise.
Craft a Compelling Cover Letter: Write a cover letter that not only summarises your qualifications but also expresses your enthusiasm for the role and the company. Make sure to connect your skills to the company's mission and the specific challenges they face in the medical device industry.
How to prepare for a job interview at Cure Talent
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and FDA QSR before the interview. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise and understanding of regulatory compliance.
✨Showcase Your Experience
Be ready to provide specific examples of your experience with design control activities, including managing Design History Files (DHF) and Device Master Records (DMR). Highlight any successful projects where you contributed to product quality and compliance.
✨Cross-Functional Collaboration
Since the role involves working closely with various teams, prepare to discuss your experience in cross-functional collaboration. Share examples of how you've effectively communicated and worked with engineering, manufacturing, and regulatory teams to drive product quality.
✨Problem-Solving Mindset
Be ready to talk about how you've handled challenges in quality assurance, particularly in relation to risk assessments and CAPA activities. Demonstrating a proactive approach to identifying trends and implementing solutions will show your value to the team.
