Quality System Manager with QMS experience within medical devices, required by market-leading Galway multinational. The successful candidate will manage processes and people to ensure regulatory compliance
- Manage the Quality System team and ensure that both regulatory and business requirements are met.
- Responsible for processes within Document Control, Customer Quality, and Master Data area.
Leader 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.
- Ensure adequate monitoring and measurement of processes.
- Ensure Quality System processes are lean, compliant, user-friendly.
- Be responsible for Health & Safety within assigned areas.
- BSc. in Quality Assurance or Science / Engineering with an additional qualification in Quality Assurance.
- 3+ years Quality Systems Manager experience within the Medical Device industry.
- Excellent working knowledge of ISO13485 and FDA QSR requirements.
- Regulatory experience / knowledge.
- Good organization, supervisory, technical writing and investigation skills.
- Proven ability to influence.
- Must be authorised to work in Ireland
Please contact Emer Moore to discuss in confidence