Our client a global medical device company who are setting up operations here in Galway are looking to hire a Quality Systems Manager. This role can be worked remote here in Ireland.
As the Quality Systems Manager you will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.
- Lead and develop the Quality System function to deliver a best in practice Quality System driving performance and compliance.
- Take responsibility for compliance with Quality System including, Management Review Coordinator, CAPA, Document Control, Training, Product Quality Review,, Internal Audit, Complaints, as well as Continuous Improvement and Simplification Initiatives.
- Ensure that products manufactured meet the requirements of end-users, Regulatory Authorities and the company.
- Develop and maintain performance measurements of the quality system and report on this at management review meetings and during quality performance meetings
- You will liaise with Regulatory bodies to ensure Quality Systems compliance by all departments and personnel.
- Manage ongoing Quality Systems Compliance issues, and present technical data to stakeholders to ensure prompt decisions on related issues.
- A degree in Engineering, Technology, or Science.
- 10+ years’ experience working in a regulated medical device company
- Demonstrated audit/inspection experience.
- Excellent verbal and written communication skills
- In-depth knowledge of QMS Requirements and Regulations
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate quality / regulatory concepts effectively.
- Excellent understanding of EN ISO 13485 and FDA regulations.
- Formal Audit Training.
- Some travel may be required with the role.
For more information or a confidential discussion about this role please contact Michelle McInerney
091 706 717