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Senior Quality Engineer NPI

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 22625

Our client a major multinational based here in Co Galway are looking to hire a Senior Quality Engineer NPI.

The Role:

As the Senior Quality NPI Engineer you will provide quality engineering support and leadership to NPI and Operations Teams.


  • Lead and effectively deliver all quality related aspects of New Product Introduction, ensuring all customer requirements are identified, documented, understood and met.

  • Be part of project teams. Deliver on commits to schedule and budget.

  • Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are always maintained.

  • Ensure processes are validated in accordance with customer and the Quality System requirements. Write validation protocols, reports and test reports as required.

  • Ensure that all customer requirements are identified, clearly documented in the manufacturing documentation and effectively implemented.

  • Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and customer requirements. 

  • Lead and investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the CAPA system.

  • Ensure the Quality System is fully compliant with customer and regulatory requirements.

  • Lead the implementation of Structured Problem Solving to drive root cause identification for process and product issues.

  • Drive and implement continuous improvement to processes and product quality.

  • Perform an active role in further development of the quality management system.

  • Supervision, coaching and mentoring of Quality Technicians and Quality Engineers.

  • Work with suppliers and customers on the resolution of product quality issues and quality improvement programs.

  • To take on other duties which the Company may assign you from time to time. 

  • Keep your skills current and be conversant with the latest developments which are relevant to the Company’s business. 


  • Bachelor’s degree in Science, Engineering, Manufacturing or related field.

  • Thorough knowledge of medical devices quality systems (ISO13485/FDA).

  • A minimum of five years of relevant progressive experience within a similar environment role.

  • Experience of New Product Introduction and manufacturing process transfer.

  • Strong Structured Problem Solving and Root Cause Analysis experience (Lean 6 Sigma Green Belt desirable).

  • Strong leadership and people management skills.

  • Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).

  • Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies.

  • Good interpersonal skills, team player, with a positive attitude in dealing with people. 

  • Must be innovative and be driven to implement change to systems and procedures.

  • Excellent analytical skills. Ability to define problems, collect data, establish facts, and draw conclusions.

  • Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

091 706717