Are you a people orientated Senior Quality Systems Engineer seeking a fresh opportunity in Galway?
This is a great role for someone looking to step up into a Management role.
Medical Devices experience is essential.
Call Rachel for more details oe apply today for more details or call 022 46969 or 087 9669394
- Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training and appraisal of QS staff.
- Responsible for processes within Document Control, Customer Quality and Master Data area.
- To take a leadership role in driving improvement initiatives in the Quality Management system across the site.
- Drive and enhance a compliance culture though-out the site.
- Providing Quality Systems support for all business units and sites.
- Preparing for and supporting external audits (TUV, FDA, customer etc).
- Ensure adequate monitoring and measurement of processes, and reporting same to management.
- Ensure Quality System processes are lean, compliant, user-friendly and are well understood through-out the organization.
- Be responsible for Health & Safety within assigned areas
- Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification in Quality Assurance.
- Experienced Quality Systems Manager with a minimum of 3 years experience at that level within the Medical Device or related industry.
- Excellent working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements.