Description
Responsibilities / Duties:- As part of a cross functional team involved in Change Control (CC) & New Product Introductions (NPI), supporting
the Quality Engineering elements of these processes, updating and improving the Quality System as required.
- Support all steps of the CC & NPI processes, mainly:
- Initial Quality Assessment
- Vendor Selection, Assessment & Qualification
- Validation Requirements
- Provide input from a quality perspective to product & process risk assessments, pFMEA
- Pilot Production & Product Approval
- Ongoing Quality & Regulatory requirements
- Liaise directly with vendors & customers.
- Provide support to Quality System elements: validation, metrology, document control.
- Support the CAPA system, continuous improvement activities, internal audit system.
- Liaise with other departments as required as part of day-to-day activities.
Requirements:
* Third level qualification in Quality Assurance / Engineering or related discipline.
* Minimum 3 years in a similar role in the medical device industry
* Knowledge of ISO, MDD, FDA requirements
* Proven track record in a similar role
* Strong project management capabilities.
* Excellent attention to detail and accuracy
* Excellent oral & written communication skills
If you are interested in this exciting contract opportunity or are aware of somebody who is please contact me directly on or visit our website www.realstaffing.com for further job information.
The Real Staffing Group is currently ranked in the top 4 suppliers to the Medical Device & Pharmaceutical Industries globally.
To find out more about Real please visit www.realstaffing.com