Design Quality Engineer, Medical Devices
Salary: Competitive, plus additional benefits: Up to 7% bonus, life insurance, pension etc
Our Client, an established Medical Devices manufacturer are looking to recruit for an experienced Design Engineer to work at their modern R&D facility located in Cheshire. The successful Candidate will play a key part in the growth of the design and development team. This is a new role for this company and therefore there are no restrictions in terms of progression. This is an excellent opportunity for somebody to work in a hybrid -quality and design 360 role.
To review, identify and support the remediation of design history files relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards and comply with regulatory/compliance standards.
- Review of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and Performance Requirements specified within the MDR legislation.
- Ensure that all product testing data is remediated or developed to MDR standards. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
- Update existing processes for maintenance/creation of design history files and other supporting documentation. In line with MDR requirements.
- Prepare Design History files and other required supporting documentation in line with MDR regulatory submission timelines.
- Any other reasonable duties as directed by the line manager.
- Will hold a Degree in a relevant Scientific/ Engineering discipline
- Will have a strong understanding of 13485 Medical Devices standards
- Design History File experience
- Understanding the impact of regulatory requirements (eg. GMP's, ISO 13485, ISO 14971, MDD and MDR)
- Must be able to provide and implement solutions
- Ability to plan and schedule multiple projects and tasks