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Quality Engineer - Medical Devices, Twickenham
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Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
73e6dbe6f4c5
Job Views:
8
Posted:
25.08.2025
Expiry Date:
09.10.2025
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Job Description:
We have an exciting new role for a Quality Engineer to join an innovative and growing Biomedical Devices company. You will be part of an experienced team with the vision to expand globally. This role offers the opportunity to impact the company by introducing new technology to new regions.
Main responsibilities include:
* Managing technical documentation, CAPA, and maintaining processes and procedures in compliance with ISO13485 QMS. Verification and validation of ISO processes.
* Managing Technical Files.
* Maintaining and updating the Risk Management File (RMF) according to ISO14971.
* Participating in three new design projects, including managing technical documentation during the design process.
* Conducting internal audits and supporting external audits.
* Supporting FDA registration for new products and registering products in various regions.
* Supporting the Post-Market Surveillance (PMS) system.
* Collaborating with Purchasing to maintain a list of approved critical suppliers, including risk classification.
Essential skills:
* Degree in Biomedical or Engineering discipline.
* Fluent in written and spoken English at C1 level.
* Understanding of MDR/ISO-13485 reporting requirements.
* At least 3 years of experience in a quality role within a medical device company.
If you are seeking your next career step in engineering at a growing, innovative company based in Twickenham, please send your application.
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