Quality Technician - Galway

Role Description

Quality Technician - Galway

Quality Technicians required for our client in Galway. Quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMP's of all medical device regulatory agencies (e.g. FDA, ISO and MDD).

Job Overview

  • Quality support for areas of responsibility.
  • Review and assessment of all quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas as appropriate.
  • Preparation of daily/weekly/monthly metrics for areas of responsibility.
  • Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective actions to improve product quality and output.
  • Participation in retrospective validation, prospective validation or revalidation of products/processes/tooling or methods as necessary.
  • Providing guidance, direction to product line Quality Assurance Auditors, Supervisors, Team Leads and Production Operators on quality aspects of products.
  • Conduct product release testing, involving sample collection, testing, documentation and communication of results; perform Work Order ‘Close outs’ – Finished Goods Sterile Product.
  • Preparation of quality reports for quality meetings and reviews.
  • Supporting internal and external regulatory audits.
  • Quality System support to production teams / quality engineers as required. 
  • Initiation of initial release / document changes ECN/ECO for procedures relevant to all tasks.
  • Other related quality tasks as required.

 

Requirements

  • Diploma in Engineering / Science or equivalent qualification; Diploma in Quality although not required is desirable.
  • Minimum of 1 years’ experience in a quality environment, preferably in Healthcare/Medical Device industry.
  • Knowledge of basic quality principles and ability to utilize these methods in a manufacturing environment.
  • Strong interpersonal and organisational skills and the ability to work effectively as a team member.
  • Self-directed/starter:  Ability to work under strict time constraints; meet deadlines in a timely manner with minimal guidance. 
  • PC skills with a good working knowledge of Word, Excel etc. Oracle knowledge an advantage.

 

For an immediate interview please forward your CV using the link provided

Or call Fiona Rattigan on 091507515 for an immediate interview

Visit www.cpl.ie for more Quality jobs

 

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