Job Summary:

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.

Job Responsibilities/Duties:

• 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.

Education/Experience:

• 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

Specific Requirements::

• 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.