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Quality Systems Engineer

Job description

Work for a growing medical device company that values customer focus, teamwork, respect, integrity, communication and innovation. They are already a large presence in the medtech sector globally and their Galway site will be further delving into cardiovascular devices in the near future.

Responsibilities: 

  • Ensure compliance to ISO13485, FDA QSR and DMR.
  • Co-ordinate the complaint program, managing the metrics for both complaints and CAPAs.
  • Act as SME for internal audits, complaint handling and CAPA handling in relation to the eQMS.
  • Provide leadership to develop and implement new techniques and initiatives to improve QMS.
  • Assist in managing and improving the QMS for the site.
  • Compile weekly and monthly quality reports.
  • Generation of ECO’s and change control documentation as required.
  • Perform Quality Systems Trending and review raw data for Quality KPIs and trending for Operations Reviews.

Requirements: 

  • Engineering or science degree with a good working knowledge of QMS management and improvement in a medical device or similarly highly regulated environment.
  • Knowledge of eQMS modules / processes such as Complaints, CAPA etc.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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