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Senior NPI Quality Engineer

1 month ago

Galway, Galway, Ireland TN Ireland Full time

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Here at Hays Recruitment, our leading medical device client is hiring a Senior NPI Quality Engineer on a full-time basis in their manufacturing facility based outside Galway city. This organisation specialises in the manufacture of plastics used to create complex catheters for investigation and discovery through injection moulding practices and techniques.

Your new role

  1. Lead and effectively deliver all quality related aspects of New Product Introduction, ensuring all customer requirements are identified, documented, understood and met.
  2. Be part of project teams.
  3. Deliver on commits to schedule and budget.
  4. Ensure processes are validated in accordance with customer and Quality System requirements.
  5. Write validation protocols, reports and test reports as required.
  6. Ensure that all customer requirements are identified, clearly documented in manufacturing documentation and effectively implemented.
  7. Assess all product and manufacturing related changes, deviations and reworks, for their impact on validation, product quality and customer requirements.
  8. Lead and investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the system.
  9. Ensure the Quality System is fully compliant with customer and regulatory requirements.
  10. Lead the implementation of Structured Problem-Solving to drive root cause identification for process and product issues.
  11. Drive and implement continuous improvement to processes and product quality.
  12. Perform an active role in the further development of the quality management system.
  13. Supervision, coaching and mentoring of Quality Technicians and Quality Engineers.
  14. Work with suppliers and customers on the resolution of product quality issues and quality improvement programs.
  15. To take on other duties which the Company may assign you from time to time.
  16. Keep your skills current and be conversant with the latest developments which are relevant to the Company's business.

What you'll need to succeed

  1. Bachelor's degree in Science, Engineering, Manufacturing or related field.
  2. Thorough knowledge of medical devices quality systems (ISO13485/FDA).
  3. A minimum of five years of relevant progressive experience within a similar environmental role.
  4. Experience of New Product Introduction and manufacturing process transfer.
  5. Strong Structured Problem-Solving and Root Cause Analysis experience (Lean 6 Sigma Green Belt desirable).
  6. Strong leadership and people management skills.
  7. Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
  8. Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies.
  9. Good interpersonal skills, a team player, with a positive attitude to dealing with people.
  10. Must be innovative and be driven to implement changes to systems and procedures.
  11. Excellent analytical skills.
  12. Ability to define problems, collect data, establish facts, and draw conclusions.
  13. Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

What you'll get in return

A permanent position with benefits included with the chance to forge a long-term career with a US company. Competitive salary while working in the exciting NPI projects space.

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