Job Description

NPI Quality Engineering Manager - South Dublin.

Ref No: SF172300

Co. Dublin, Ireland

Competitive salary

NPI Quality Engineering Manager - South Dublin.

Core Purpose:

In this position you will play a pivotal role in site process improvement activities, and be the central point of contact for key customers.

Key duties will include management and approval of process validation studies, project management, application of SPC to current production processes and liaison with key stakeholders.
Other key duties will involve leading and directing the New Product Quality Engineering team.


Core Responsibilities:
To provide support for the ISO13485 Quality System.

  • Responsible for ensuring adherence to all company, external and appropriate regulatory requirements.
  • Act as a key member of the Quality Leadership Team.
  • Support production personnel in relevant continuous improvement activities (Six Sigma).
  • Day to day leadership/management of New Product Quality Engineering team. Manage and develop the team through involvement, delegation, and regular reviews of performance.
  • Set up & management of key quality system elements relating to direct production support, such as the non-conformance system, incident reporting system and customer complaint analysis.
  • Management of Quality control group and their activities to meet project goals
  • Driving key changes and improvements in the Quality assurance and control systems.
  • Liaise with key external suppliers and customers.
  • Ensure all CAPA's under your responsibility are completed in compliance with all regulatory and procedural commitments
  • Prepare and maintain documentation in compliance with appropriate regulatory requirements.
  • Supporting key changes and improvements in manufacturing relating to product quality.
  • GMP oversight and compliance of Production and Quality Engineering activities.
  • Supporting key changes and improvements in manufacturing relating to product quality
  • Provide Quality Engineering Support and Leadership for key clinical builds
  • 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

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