Telephone: 086 8395533
Quality System Manager
Our client, a medical device company in Galway is currently looking to recruit a Quality Systems Manager for their site.
The Quality System Manager is responsible for managing the processes and people within the Quality Systems dept to ensure that the company is in compliance with all applicable regulatory and business requirements.
- 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
- Any other duties assigned from time to time
- 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.
- Regulatory experience / knowledge.
- Good organization, supervisory, technical writing and investigation skills are required.
- Excellent communication and inter-personal skills.
- Proven ability to influence.
- U.S. Food and Drug Administration (FDA)
- Lean Manufacturing
- Medical Devices
- Document Management
- Quality System
- Technical Writing
- ISO 13485
- Quality Assurance
- Bachelor's Degree
For further information on this Quality Systems Manager role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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