This Job Vacancy has Expired!

Senior Quality Engineer

Real Staffing Group

Posted on Oct 2, 2021 by Real Staffing Group

Macroom, Cork, Ireland
Immediate Start
Annual Salary

My client in Cork who is a medical Device multinational are looking for a Senior Quality Engineer with NPI to join their team on a 18 month contract with possibility to go perm.

Title: Senior NPI Quality Engineer

Location: Macroom, Cork

Benefits: Excellent salary, pension, healthcare and yearly bonus


  • Work in a cross functional team with Project Management, Process Development (PD), R&D, Design Quality, Operations and Supplier Management to ensure successful launch of the new product.

  • Ensure all process changes/process improvements are risk assessed by promoting the GO SEE Principle and FOCUS ON PROCESS Principle.

  • Provide feedback to the R&D teams to ensure the new product is designed for manufacturing.

  • Drive risk reduction and eliminate risks and introduce error proofing through the Risk Management process.

  • Develop and agree with the master validation strategy for the new product manufacturing process.

  • Review and approval of all process characterisation, process validation & test method validation documentation.

  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (eg Use of DOE studies, FMEA's).

  • Complete Attribute TMV's on new product projects.

  • Ensure compliance at all stages of Product Lifecycle Development Process. Reviewer of change notices for product, process and system changes, validation builds and eCAPA phases. Promote a right first time behaviour within the New Product Project Teams.

  • Provide regular updates to site management on progress of new product introduction activities.

  • Support the compilation of documentation for Regulatory submissions for new products.

  • Ensure that there is clear handover of quality responsibilities from the Project team to the SBSC cork Operations team.

  • Ensure the line is set-up meeting the site 5S and cGMP requirements

  • Ensure all Non-conformances and CAPA's are completed in a timely manner.

  • Support the internal audit program.


  • Requires a minimum level 8 relevant Engineering/Science degree

  • Experience in NPI

  • Minimum of 3+ years' experience within Quality department in medical device or pharmaceutical manufacturing industry

Would you be interested in having a chat about this role further?

If so forward me your up to date CV or let me know a time that works for you to take a call and we can set it up.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Reference: 1343099962

Set up alerts to get notified of new vacancies.