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.