Project Engineer/design Quality Engineer

1 day ago


Nottingham, United Kingdom Roc Search Limited Full time

Location - Nottingham - Hybrid 2/3 days onsite
Salary - Dependent on experience up to £55,000
Employment type - Permanent
Urgency - ASAP (will consider notice periods)

**Key Responsibilities**:

- Generate project documentation, in line with requirements of ISO 13485:2016, 21 CFR Part 820 and other applicable regulatory requirements, including but not limited to user needs, design inputs, design outputs, verification and validation
- Lead the compilation of product Design History Files (DHFs)
- Develop, and help execute, verification and validation activities for projects
- Support the design transfer of product from development to manufacture
- Support risk management activities in line with requirements of ISO 14971
- Work closely with quality assurance on ensuring compliance to internal Quality Management System (QMS), ISO 13485:2016 and 21 CFR Part 820
- Support project managers in the coordination and delivery of tasks in accordance with the project plan

**Must have experience**:

- Degree level qualification, or equivalent experience, in a science or engineering discipline
- Previous experience in the medical device sector working to requirements of ISO 13485:2016 and 21 CFR Part 820
- Experience authoring technical and scientific documentation in support of medical device Design History Files (DHFs).
Please send CV for a call back


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