Quality Assurance Technician 9 month FTC

  • Full Time
  • Galway

Website MeritMedical Merit Medical Ireland Ltd

Merit Medical Ireland Ltd

Quality Assurance Technician 9 month FTC

A number of vacancies currently exist within the Quality Department on evening and weekend shift:

Summary of Duties/Responsibilities:

  • 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).
  • 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.

Summary of Qualification/Experience:

  • 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.

Merit Medical is an equal opportunity employer

To apply for this job please visit recruiting.adp.com.