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View Cache (Job ID 13850570)
Employer Pe Global
Job Title Quality Engineer

Responsibilities of the role:

  • Review and approval of validation documentation (protocols & reports)as a quality review against the signed off VMP and customer requirements.
  • Generating, communicate and updating the document tracker.
  • Ensure the archiving and filing of validation documentation associated with the project.
  • Facilitate equipment FMEA and ensure, with the Program Manager, that the SME is trained to the FMEA process and updated on the relevant FMEA.
  • Drive the close out of change control, deviations, quality continuous improvement identified during the project.
  • Lead investigations into product issues to ensure a thorough root cause, corrective and preventive action is implemented and learning taken into Scale up.
  • Drive solutions in conjunction with the appropriate department to ensure customer related problems are communicated and corrective actions are in place and closed in a timely manner.
  • Analysing and reporting of key measures.
  • Review of quality document to drive compliance.
  • Drafting of the defect library and QSS during OQ with formal hand over to Operational Quality prior to PQ
  • Support internal and supplier audits. Play a key role in the preparation and hosting of third party and customer audits.
  • Trending and tracking of quality data to drive improvements eg Sampling data, Maternal reviews reports, project protocols and reports.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all local site Environmental, Health and Safety regulations
  • Compliance to all local site company policies, procedures and corporate policies.

Education and experience required:

  • Third level qualification in Engineering/Quality/Science.
  • 2 years experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
  • knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
  • Must have an in-depth knowledge of validations in a Medical Device environment.
  • An understanding of plastic process manufacturing would be advantageous.
  • Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.

If you are interested in this position, please forward your CV to or call Catherine on 0214297900

This job originally appeared on
Location Dublin West
Date Added 71 days ago
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