NPI Quality Manager

I8935

DPS are currently recruiting on behalf of a Pharmaceutical / Medical Device Client based in South Dublin for an NPI Quality Manager.

Category:
Control Cost
Location:
Ireland
Years of Experience Req.:
5-10 Years+
Date Posted:
16/11/2021
Days Remaining:
35
Employment Type:
Contract
Education Level Req.:
See Description

NPI Quality Manager

DPS are currently recruiting on behalf of a Pharmaceutical / Medical Device Client based in South Dublin for an NPI Quality Manager.

Responsibilities:

  • Providing support for ISO13485 Quality System.
  • Ensuring alignment to all internal, external and appropriate regulatory requirements.
  • Supporting production personnel in relevant continuous improvement activities (Six Sigma).
  • Day to day Leadership/Management of New Product Quality Engineering Team. Lead and develop the team through involvement, delegation, and regular reviews of performance as established in IIGs (goals).
  • Setup & Management of Key quality systems elements relating to direct production support such as the non- conformance system, incident reporting system and customer complaint analysis.
  • Liaise with the R&D Department to ensure compliance to Product Specifications
  • Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments
  • Develop and implement validation strategy for IQ/OQ and PQ requirements.
  • Ensure verification activities undergo test method validation to ensure consistent operation of the test equipment and results for the intended use

Requirements:

  • Third level qualification in an Engineering or Science Field (a postgraduate qualification in a related area would be advantageous).
  • A minimum of 5 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
  • Experience in the preparation of Technical Documentation.
  • At least 3 years supervisory experience.
  • Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
  • Experience in CAPA system management.

 

DPS is an Equal Opportunities Employer

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