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

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 catherine.osullivan@peglobal.net or call Catherine on 0214297900

This job originally appeared on RecruitIreland.com
Location Dublin West
Date Added 7 days ago
Apply Link
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