Medical Device Assurance Specialist
2 days ago
Skill Alliance, a world-leading medical technology company, seeks a skilled Design Assurance Engineer to join its global team in Oxford, UK.
This is an opportunity to work with innovative solutions and contribute to improving patient outcomes. The role involves ensuring regulatory compliant design life cycle documentation, confirming adherence to procedures and global standards, and participating in design verification testing.
The successful candidate will join a rapidly growing Quality department and be involved in the quality assurance of the full development lifecycle of new and existing products.
Key Responsibilities:
- Assure design quality through the full lifecycle process in accordance with standards and procedures of a class III medical device.
- Complete relevant documentation and verification test reports for devices and systems, according to documentation procedures.
- Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
Requirements:
- Bachelor's degree within an engineering discipline or equivalent.
- 3+ years of experience within quality in the medical device industry.
- Expert knowledge cGMP, 21 CFR 820, ISO13485, 14971. IEC 60601, 62304.
- Experience working in a full product development lifecycle environment, participating in design reviews, and ensuring design requirements are met.
The estimated salary range for this position is £60,000 - £80,000 per annum, depending on experience. Please note that this is an estimate based on national averages and market conditions.
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