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NPI Quality Manager

Job Seekers Ireland Life Sciences & Engineering Life Science, Manufacturing, Medical Device

Job Summary

  • Dublin
  • Permanent
  • BBBH802236
  • Aug 10, 2022
  • Competitive
Job Description

This person will play a key role in the onsite process improvement activities and will be a leading point of contact for all customers.

You will have a minimum of 5 years' experience coming from a Medical Device or Pharmaceutical Industry with extensive knowledge and experience of ISO 13485 and/or ISO 9001/2000. A minimum of 3 years' experience must be at supervisory level with experience leading CAPA system management. Third level degree in engineering or science essential. A green belt in six sigma would be advantageous but not essential.

Responsibilities:

  • Management and approval of process validation, project management and consulting with key partners.
  • Leading the NPI quality engineering team including development of the team through training/mentorship, delegation, and performance reviews.
  • Supporting all ISO13485 quality system.
  • Consulting with and support of the production team with continuous improvement activities relating to six sigma.
  • Development and implementation of validation strategies for IQ/OQ/PQ requirements.
  • Management of quality systems such as NC system, customer complaint and incident reporting.
  • Ensure the alignment to all internal, external, and regulatory requirements across the site.
  • Ensure all CAPAs are completed in line with internal and external compliance and regulatory requirements.
  • Consult with R&D regarding product specifications to ensure they are compliant.

If this role is of interest, please 'apply now.'

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll
  • Senior Consultant | Engineering Recruitment
  • +353 (0) 21 2300300
  • aodriscoll@morganmckinley.com