Quality Engineer NPI
Company: Thornshaw Recruitment
Closing Date: 18 Feb 17
Type: Maternity Cover
Salary (£): On Application
A multinational medical device manufacturer are looking for a Quality NPI Engineer to cover an initial maternity contract.
- Review and approval of validation documentation.
- Generate, communicate and updating the document tracker.
- Facilitate equipment FMEA and ensure that the SME is trained to the FMEA process.
- Drive the close out of change control, deviations, quality, continuous improvement identified during the project.
- Lead investigations into material / product issues to ensure a thorough root cause and CAPA is implemented.
- Drive solutions to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
- Analysing and reporting of key measures eg. Ppk's, Cpk's. Review of quality documents to drive compliance ie validation reports, metrology reports etc.
- Drafting of the defect library and QSS during OQ with formal hand over to Operational Quality prior to PQ
- Support internal and supplier audits.
- Trending and tracking of quality data to drive improvements.
- Third level Degree in Engineering/Quality/Science.
- Minimum of 2 years’ experience working in a high volume manufacturing environment in the Medical Device / Pharmaceutical sector.
- A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
- Must have an in-depth knowledge of validations in a Medical Device environment.
- An excellent understanding of plastic process manufacturing.
- Good understanding of computer system validation.
- 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.
For more information on this role, or to apply, please contact Saoirse on 012784671 or firstname.lastname@example.org