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Quality Systems Manager

Location: Galway, Republic of Ireland Salary:
Sector: Regulatory Affairs, Quality Assurance (QA), Regulatory Affairs (RA) Type: Contract

The client is ranked among the top 10 global companies in the medical device sector. They specialise in the design and manufacturing of medical devices for a range of therapies.


As the Quality Systems Manager you will be responsible for managing the processes and people within the Quality Systems department to ensure that the company is in compliance with all applicable regulatory and business requirements.


Day - day duties:


- Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department.
- 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
- Ensure Quality System processes are lean, compliant, user-friendly and are well understood through-out the organisation.

Your skill-set:


- 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 organisation, supervisory, technical writing and investigation skills are required.
- Excellent communication and inter-personal skills.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales