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  • DUBLIN 2
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  • Job reference number:15332074
  • Client ID:RI/BBBH23156
  • Posted on:14-MAR-2018
  • Job type:PERMANENT

Our client, a global healthcare organisation with 50 years of medical device experience, have developed a thorough understanding of the complex solutions to patients needs. They operate at a global level being experts in their area and providing high level products to their customers.

The Role:

Our client is currently seeking a Quality Engineer (Systems) to join their onsite Quality team and be a key team member in implementing the QMS onsite and the project management of this process whilst also supporting the manufacturing function.

Key Responsibilities:

  • Maintain quality system in accordance with the requirements of ISO13485
  • Review batch records and approve the release of product. Release finished product, monitor product sterility and sterilisation records as appropriate
  • Liaise with customers on all product-related queries, co-ordinate Customer-Request group, drive preventive actions and improve customer confidence
  • Manage the QA document control function, overseeing change control, SOP review, document storage/archiving.
  • A key responsibility of this role will be co-ordinating the introduction of soft-format documentation via VQMS documentation system
  • Co-ordinate the CAPA system, convening the CAPA Review Board, driving corrective and preventive actions, assigning responsibilities and reporting trends
  • Lead/support Projects as required
  • Complete internal and vendor/contractor audits. Oversee the gowning and cleaning regimes in place, working with contractors to improve performance and maintain a clean environment
The Person

  • Degree qualified in quality management, engineering or science with minimum 5 years medical device/pharmaceutical and/or diagnostics manufacturing experience.
  • 1 year experience in a quality department is desirable.
  • Must have a good working knowledge of ISO13485, FDA Quality System Regulations.
  • Ability to lead and conduct audits, and implement QMS.
To learn more apply online or contact Orla Boyle at HRM directly on 353 91 782110 for a confidential chat.

This job originally appeared on RecruitIreland.com