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Job Details

Quality Engineer NPI

Company: Thornshaw Recruitment
Reference: SR9313
Closing Date: 18 Feb 17
Type: Maternity Cover
Salary (£): On Application

Job Summary:

A multinational medical device manufacturer are looking for a Quality NPI Engineer to cover an initial maternity contract.


Role Description:

  • 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

Apply for this job: Quality Engineer NPI

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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