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Job Details

Senior Quality Engineer (NPI) Work Package Manager

Company: Thornshaw Recruitment
Reference: SR9314
Closing Date: 17 Mar 17
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client, a multinational medical device manufacturer now have a vacancy for a Senior Quality Engineer.


Role Description:

  • 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

Apply for this job: Senior Quality Engineer (NPI) Work Package Manager

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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