Our client is a medical device manufacturer with a site based in Belfast, they are a global brand with locations across the UK. We are recruiting a Quality Manager to join the senior team and manage the site quality systems.
The Role
Reporting to the Group Operations Director, the Quality Manager will maintain and oversee all aspects of the Quality systems, (To include and not limited to ISO 13485, ISO 14001, FDA standards, Medical Device Directive, CE Marking, ISO 14971). The successful applicant will provide clear direction to the Management team to ensure all processes and systems are fully compliant and work proactively to maintain a programme of continual improvement.
The Person
- Proven experience in a similar role.
- Previous leadership experience.
- Proven track record in ensuring compliance with:
- ISO13485
- Medical Device Directive – full Technical File preparation including authoring Clinical Evaluations.
- CE Marking new products.
- FDA QSR 21 CFR part 820
- Experience of managing and developing Quality System requirements in a regulated industry.
- Experience of Risk Management techniques compliant with ISO 14971 including FMEA.
This position offers an excellent salary and the chance to work in a highly motivated, versatile, interesting and exciting environment.
To discuss further contact Seamus on 02890725625, if you CV isn’t up to date we can work on that.
