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.
The ideal candidate will have:
* 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!