Job Description

  • Employment Type:
  • Job Location: Galway
  • Date Posted: Posted 6 months ago

Responsibilities

·         Manage complaints and the complaint handling system, ensuring that they are dealt with in a proper and timely manner.

·         Oversee the CAPA system, CAPAs in full and ensure investigations are carried out in line with notified body requirements.

·         Manage the audit schedule both internally and externally.

·         Assist in supplier management, selection, approval, monitoring and reporting.

·         Take ownership of the document control for the site.

·         Monitor MDR requirements for QMS.

·         Lead activities for the QMS and ensure certification to ISO, FDA, PMDA regulations.

·         Manage the software validation process.

Requirements

·         Must have at least a diploma in Engineering, Science, QA or similar discipline.

·         Should have 5 years or more experience with a working knowledge of ISO13485, 21CFR 820, MDD/MDR and Risk Management.

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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