The Company
Our client is a leading medical device manufacturer with a strong reputation for being best in class. You will be joining an innovative team that has created a life-changing product in the market. If you are a passionate, driven, and dedicated Quality Engineer who has a passion for bringing safe medical devices to market, this would be a great opportunity to join a dynamic team working with a cutting-edge product.
The Role
1. Partner with Manufacturing Engineers to develop and qualify manufacturing processes.
2. Review and approve design changes.
3. Support or lead root cause analysis investigations for production-related or quality-related non-conformities and develop and aid in the implementation of corrective actions.
4. Support elements of the Quality System such as NCRs, CAPAs, and Complaints.
5. Audit the manufacturing line to ensure compliance with governing procedures is being met.
Key Skills
1. Experience with nonconformances, investigations, root cause analysis, risk analysis, and corrective/preventive actions.
2. Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.
3. Must have strong project management and documentation skills.
4. Must take initiative and have the ability to conduct hands-on work.
Benefits
1. 28 days Holiday + Bank Holiday.
2. Health Care.
3. 35hr Per Week.
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