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New Product Development – Quality Engineer, Buckinghamshire
Client:
Cpl Life Sciences
Location:
Buckinghamshire, United Kingdom
Job Category:
-
EU work permit required:
Yes
Job Reference:
32d774bef1ad
Job Views:
12
Posted:
28.04.2025
Expiry Date:
12.06.2025
Job Description:
Overview
Our client, a leading Medical Device Manufacturer, is looking to appoint an experienced Design Quality Engineer into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. They ensure compliance with and maintenance of the company's 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 reports to support design projects.
The Engineer will own and lead the completion of NCs and CAPAs associated with design projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
1. Represent the quality function within the design and development team
2. Support the design team by drafting, implementing, and executing procedures, records, and protocols for design and development projects
3. Participate in design team meetings to draft, review, and implement design projects
4. Ownership of design NCs & CAPAs, lead investigations, root cause analysis, and corrective actions
5. Develop metrics/KPIs within the QARA team to improve the company's QMS from a design and development perspective
6. Support external audit activities
Knowledge and Skills to be Successful:
* Bachelor's degree in Science, Engineering, Quality, or related field
* 2+ years’ experience in a regulated environment
* Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA QSR
* Experience with design and NPI projects, drafting and implementing quality documents
* Proficiency with Microsoft Office Suite
* Excellent English communication skills
* Experience with regulatory agencies (FDA, MHRA, TUV) is advantageous
Application Process:
To apply, please provide your full name, email address, and an optional cover message. Upload your CV and indicate if you wish to be contacted via SMS. By applying, you agree to our privacy policy.
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