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  • Job reference number:15358713
  • Client ID:RI/BWQEL2803
  • Posted on:13-JUN-2018
  • Salary:Negotiable
  • Location:LIMERICK
  • Job type:PERMANENT

A leading Medical Device manufacturer in Limerick has a number of openings for experienced Quality Engineers. An attractive salary and benefits package is on offer.

Responsibilities and Duties

  • Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Test Summaries, Software Validation, Microbiological assessments and Critical System Work Orders.
  • Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments.
  • Support the Supplier Appraisal and Approval processes.
  • Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
  • Provide input and support to the Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
  • Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes
  • Conducting, documenting and reviewing complaint investigations.
  • Risk assessment of customer complaints, Non-conformance and CAPA’s.
  • Initiate, manage and execute projects for continuous improvement within the department.
  • Designee to the Senior Quality Engineer.
Qualifications and Skills

  • Third Level qualification in Science, Engineering or a relevant technical discipline.
  • Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
  • Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
  • Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation.
  • Good working knowledge of statistics.
  • Experience in combination devices would be an advantage.
For more on the role call Nigel on 021 4221000 or send your CV for consideration.

This job originally appeared on RecruitIreland.com