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Senior NPI Quality Engineer

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Mark Wilson
+353 86 0449473
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Recruitment Consultant

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Senior NPI Quality Engineer

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Senior Quality Engineer NPI

We are excited to share a Senior Quality Engineer Opportunity with our Client who manufacture products that improve the lives of people every day, all around the world. Our Medical Device Client in West Galway are looking for a candidate with 5+ years of experience as a Quality Engineer with experience in NPI and ideally leadership skills.

Key Responsibilities:

  • 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 Freudenberg Medical's Quality System requirements. Write validation protocols, reports and test reports as required.
  • Ensure that all customer requirements are identified, clearly documented in Freudenberg Medical's 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 Freudenberg Medical's 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.
  • 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. 

Key Requirements

  • Bachelor’s degree in Science, Engineering, Manufacturing or related field.
  • A minimum of five years of relevant progressive experience within a similar environment role.
  • Experience of New Product Introduction and manufacturing process transfer.
  • Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).

For further information on this role in please contact Mark Wilson on 0860449473 or email

Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

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