Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISOI 3485:2016, MDSAP and FDA requirements. The role 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 and team to deliver a best in practice Quality System driving performance and compliance.
- Take responsibility for compliance with Quality System including, Management Review Coordinator, Management Representative, Supplier Program, CAPA, Change Control, Training, Product Quality Review, Inspection Readiness & Management, 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 the Quality and Compliance Group, FDA, HPRA and other 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.
- Other work as assigned by the Managing Director.
- A degree in Engineering, Technology, or Science.
- 10+ years’ experience working in a regulated medical device company
- Minimum of 3 years people management experience.
- Demonstrated audit/inspection management experience.
- Excellent verbal and written communication skills
- In-depth knowledge of GMP 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 13485:2016, MDSAP ad FDA regulations.
- Formal Audit Training.
- Proficiency in use of desktop software applications such as MS office.
- Some travel may be required with the role.