Senior Quality Systems Engineer (MDR Implementation)

Posted 09 December 2019
SalaryNegotiable
Location
Job type Temporary
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ReferenceBBBH27080_1575910259
ContactPaul Wheatley

Job description

Our client is a truly global business operating across over 40 countries and with recent performance this has positioned them as a genuine market leader in the health sector. They are highly focussed and with a recent substantial multi-million euro investment will continue to lead into the future. As such they require a Senior Quality Engineer to join their team in Waterford.

The Position:

As a Senior Quality Engineer, provide support to the MDR team and ensure all required objectives associated with 2017/745 (MDR) are implemented.

In addition, responsibilities will include:

  • Assist with the execution of Medical Device Regulation in the manufacturing plant as identified by the MDR Project team
  • Implement any plant quality systems changes as identified by the MDR Project team
  • Implement plant change management activities for the implementation of MDR QMS requirements
  • Provide Supplier Quality support to any supplier changes / material changes that will occur due to MDR
  • Support new MDR Requirements around post market surveillance
  • Work closely with the plant ensuring clear communication of any new MDR requirements
  • Support risk management, risk analysis and health hazard analysis associated with post market information.
  • Additional requirements of the job will be specified by the Quality Systems Manager

The Person

You will have a minimum of 5 years' experience in a Quality role. A third level qualification, ideally in engineering or science is required.

To discover more about this opportunity, apply now or contact Paul Wheatley at HRM on +353 21 4511190 for a confidential discussion.