Design Assurance Engineer Job - Hourly Rate Contractor Role for 12-18 months - Remote Working/Hybrid Option Available!
The role will focus on review and remediation of our current product offerings to ensure compliance with MDR requirements.
- Work as member of a MDR remediation Team to critically analyse & distil applicable regulatory standards & requirements, assimilate design data and generate/configure technical studies and rationales to fulfil requirements and augment design history files.
- Review, assessment and where applicable, update Risk Management Documentation to MDR requirements.
- Review of all process documentation associated with the product remediation in the context of MDR requirements.
- Provide guidance, direction and supervision to QA Technical Staff where appropriate..
- Bachelor’s Degree in Engineering or equivalent technical qualification.
- 3-5 years’ experience in a similar role / environment.
- Experience in the creation of Design Control / Design History File documentation in line with Regulatory Requirements (Preferably MDR).
- Working Knowledge of the requirements and application of ISO14971:2019.
- Good working knowledge of regulatory standards and industry practices for Medical Device Manufacture including MDR
- Proven ability to review complex documents and assimilate information with a high level of detail and accuracy.
You should also have the following abilities/skills/qualities:
- Ability to work under strict time constraints; meet deadlines in a timely manner with minimal guidance.
- Team player: Ability to work and communicate effectively as part of QA and cross functional / organisational teams; be flexible with a ‘can do’ attitude.
- Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
- Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to clearly and informatively write technical documentation, routine reports, correspondence, procedures and work flows.
- PC Skills: Standard offices packages and ability to understand and learn customized computer software programs.
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