Senior Quality Engineer (NPI) Work Package Manager
Company: Thornshaw Recruitment
Closing Date: 17 Mar 17
Type: Full Time
Salary (£): Negotiable
Our client, a multinational medical device manufacturer now have a vacancy for a Senior Quality Engineer.
- Reporting on project progress, identifying successes, driving compliance via validation master plan (VMP) / customer specification. Escalated to the Program Manager / Quality & Regulatory Manager as required.
- Responsible for the introduction of quality requirements of new or transferred products.
- Responsible for the generation of a Risk Management Plan for the project covering quality, supplier chain, timeline and commercial risks.
- Facilitate equipment FMEA and ensure with the Program Manager that the SME is trained to and updated on the relevant FMEA.
- Generation of the VMP and defining the documentation path the project will take
- Review and approval of validation documentation
- Support the initiation and completion of the Quality Function Deployment in a timely manager
- Support timely analysis of metrology data at the various stages
- Drive the close out of change control, deviations, quality continuous improvement identified during the project.
- Third level qualification in Engineering/Quality/Science with minimum of 5 years’ experience of working in a high volume manufacturing environment in the medical device / pharmaceutical sector.
- Must have an in-depth knowledge of validations in a medical device environment.
- An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems
- Must have a thorough understanding of statistics, SPC, and ideally the use of minitab.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.
- A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
- Knowledge of 21 CFR Part 210 / 211 would be considered an advantage
For more information, or to apply, please contact Saoirse on 012784671 or email@example.com