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- Tasks: Join a dynamic team as a Design Quality Engineer, ensuring top-notch quality in medical device projects.
- Company: Work with a leading Medical Device Manufacturer known for innovation and excellence.
- Benefits: Enjoy a flexible work environment and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while developing your skills in a supportive culture.
- Qualifications: Bachelor's degree in Science or Engineering; 2+ years in a regulated environment required.
- Other info: Experience with ISO standards and regulatory agencies is a plus.
The predicted salary is between 36000 - 60000 £ per year.
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New Product Development – Quality Engineer, buckinghamshire, uk
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Client:
Cpl Life Sciences
Location:
buckinghamshire, uk, United Kingdom
Job Category:
Other
–
EU work permit required:
Yes
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Job Reference:
32d774bef1ad
Job Views:
31
Posted:
12.08.2025
Expiry Date:
26.09.2025
col-wide
Job Description:
Overview
Our client a leading Medical Device Manufacturer is looking to appoint an experienced Design Quality Engineering into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. The Design Quality Engineer will ensure compliance with and maintenance of the companies QMS and regulatory requirements within design documents, records and processes.
The Design Quality Engineer will draft and execute required design project documentation such as FMEAs, Validation Protocols, DMRs, Verification testing and technical report writing, etc. to support the execution of design projects.
The Design Quality Engineer will own and lead the completion of NCs and CAPAs associated with design projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Represent the quality function within the design and development team
• Support the design team by drafting, implementing and executing procedures, records and protocols for design and development projects
• Participate in design team meeting to draft, review and implement design projects
• Ownership of design NCs & CAPAs, lead investigations, root cause analysis and corrective action implementation
• Develop metrics/KPIs within the QARA team to implement, maintain, and improve the companies QMS from design and development perspective
KNOWLEDGE AND SKILLS TO BE SUCCESSFUL IN THE JOB
Education Required: Bachelor degree in academia e.g. Science, Engineering, Quality or equivalent/ related subject.
Education Preferred: Engineering/Science Degree Years of related experience: 2+ years’ experience in a regulated environment.
Quality systems, auditing and supplier/purchasing controls, engineering or equivalent experience desirable.
(Medical Device, automotive, aerospace. Electronics Med Device preferable)
REQUIREMENTS:
• Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System Regulations
• Electronic technical knowledge and experience
• Experience of creating and executing Design/NPI – New Product Introduction projects, preferably within the quality function
• Experience of drafting and implementing Design/Quality documents and protocols: e.g. Validation, FMEA, test documents, etc.
• Must be able to work within a team in a dynamic environment and interact effectively at all levels and across all functions within the organization
• Flexible mindset to adapt to evolving requirements within a small, dynamic work environment
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
• Excellent English (both oral and written)
• Experience in interacting with regulatory agencies (FDA, MHRA, TUV, etc.) advantageous
• Ability to be the voice of quality when dealing cross functionally with development & other departments
Apply
Full name Email address Cover Message (optional) Upload CV Choose File Upload your CV and any other relevant file. Contact via SMS (optional) I would like to be contacted via SMS Privacy Policy I have read and agree to the Clinical Professionals Group Privacy Policy
Overview
Our client a leading Medical Device Manufacturer is looking to appoint an experienced Design Quality Engineering into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. The Design Quality Engineer will ensure compliance with and maintenance of the companies QMS and regulatory requirements within design documents, records and processes.
The Design Quality Engineer will draft and execute required design project documentation such as FMEAs, Validation Protocols, DMRs, Verification testing and technical report writing, etc. to support the execution of design projects.
The Design Quality Engineer will own and lead the completion of NCs and CAPAs associated with design projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Represent the quality function within the design and development team
• Support the design team by drafting, implementing and executing procedures, records and protocols for design and development projects
• Participate in design team meeting to draft, review and implement design projects
• Ownership of design NCs & CAPAs, lead investigations, root cause analysis and corrective action implementation
• Develop metrics/KPIs within the QARA team to implement, maintain, and improve the companies QMS from design and development perspective
• Support external audit activities
KNOWLEDGE AND SKILLS TO BE SUCCESSFUL IN THE JOB
Education Required: Bachelor degree in academia e.g. Science, Engineering, Quality or equivalent/ related subject.
Education Preferred: Engineering/Science Degree Years of related experience: 2+ years’ experience in a regulated environment.
Quality systems, auditing and supplier/purchasing controls, engineering or equivalent experience desirable.
(Medical Device, automotive, aerospace. Electronics Med Device preferable)
REQUIREMENTS:
• Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System Regulations
• Electronic technical knowledge and experience
• Experience of creating and executing Design/NPI – New Product Introduction projects, preferably within the quality function
• Experience of drafting and implementing Design/Quality documents and protocols: e.g. Validation, FMEA, test documents, etc.
• Must be able to work within a team in a dynamic environment and interact effectively at all levels and across all functions within the organization
• Flexible mindset to adapt to evolving requirements within a small, dynamic work environment
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
• Excellent English (both oral and written)
• Experience in interacting with regulatory agencies (FDA, MHRA, TUV, etc.) advantageous
• Ability to be the voice of quality when dealing cross functionally with development & other departments
Apply
Full name Email address Cover Message (optional) Upload CV Choose File Upload your CV and any other relevant file. Contact via SMS (optional) I would like to be contacted via SMS Privacy Policy I have read and agree to the Clinical Professionals Group Privacy Policy
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Created on 12/08/2025 by TN United Kingdom
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New Product Development – Quality Engineer employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land New Product Development – Quality Engineer
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements mentioned in the job description, such as ISO 14971 and ISO 13485. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality engineering in the medical device sector.
✨Tip Number 2
Engage with online communities or forums related to quality engineering in medical devices. Networking with professionals in the field can provide insights into the latest trends and challenges, which could be beneficial during your discussions with the hiring team.
✨Tip Number 3
Prepare to discuss your experience with Non-Conformance (NC) and Corrective Action Preventive Action (CAPA) processes. Be ready to share specific examples of how you've led investigations and implemented corrective actions in previous roles.
✨Tip Number 4
Brush up on your technical skills, especially with Microsoft Office tools like Word, Excel, and PowerPoint. Being proficient in these applications is crucial for drafting documents and presenting findings effectively during the interview process.
We think you need these skills to ace New Product Development – Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality engineering, particularly in regulated environments like medical devices. Emphasise your familiarity with ISO standards and any specific projects you've worked on that align with the job description.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific skills and experiences that relate to the essential duties listed in the job description, such as your experience with FMEAs and CAPAs.
Showcase Technical Skills: Highlight your proficiency with Microsoft Office tools, especially Word and Excel, as well as any electronic technical knowledge you possess. This is crucial for drafting and executing design project documentation.
Demonstrate Team Collaboration: Provide examples of how you've successfully worked within a team in dynamic environments. Mention any cross-functional projects where you represented quality functions, as this aligns with the responsibilities of the role.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Familiarise yourself with key regulatory requirements such as ISO 14971 and ISO 13485. Being able to discuss these standards confidently will demonstrate your understanding of the quality landscape in the medical device industry.
✨Showcase Your Technical Skills
Be prepared to discuss your experience with electronic technical knowledge and how it relates to design projects. Highlight specific examples where you've applied this knowledge in previous roles.
✨Prepare for Team Dynamics
Since teamwork is crucial in this role, think of examples that showcase your ability to work collaboratively in a dynamic environment. Be ready to explain how you’ve effectively interacted with cross-functional teams in the past.
✨Demonstrate Problem-Solving Abilities
Expect questions about how you've handled non-conformances (NCs) and corrective actions (CAPAs). Prepare to share specific instances where you led investigations and implemented solutions, showcasing your analytical skills.
