Quality Systems Specialist

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Role

Reporting to the Quality Manager – Blarney Operations, the Quality System Specialist is responsible for maintaining compliance of the Quality Management System to applicable quality and regulatory standards.

Duties

•    Coordination of the preparation for audits, including but not limited to
-Scheduling audits
-Onsite audit preparation (booking rooms, audit preparation etc)
-Running backroom/front-room as appropriate
•    Participation in audits as SME for QMS related topics
•    Coordination of corrective actions, compiling and issuing responses to audit reports
•    Conduct audit readiness walkabouts with site operations team
•    Creating audits on Veeva, generating CAPA action plans, tracking CAPA actions with site operations team, and effectivity verification
•    Compiling site metrics for quality system performance
•    Supervision and development of Quality Systems staff if/when required 
•    Driving and implementing Quality System improvements across the site
•    Responsible for maintaining all QMS documentation 
•    Maintenance of Standards, coordination of gap analyses, and disseminating updates to revelent departments. 
•    Respond to customer requests or enquiries
•    Oversight and management of document archiving process
•    Additional duties as requested by your manager

Who You Are

•    Degree in an appropriate science discipline and at least 3 years relevant Quality Systems experience in the Medical Device/Pharmaceutical industry.
•    Excellent written and oral communication skills.
•    Supervision and planning skills.
•    Extensive experience using CAPA/Deviation & Change Control electronic systems 
•    Lead Auditor training and experience in auditing is a distinct advantage

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!