Principal Quality Engineer

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 Principal Quality Engineer will be responsible for managing and delivering on all aspects of the Quality Function related to the assigned area.

The Principal Quality Engineer works as part of a cross-functional team to ensure compliance to quality systems and will drive, support and implement continuous improvement projects. 

The Principal Quality Engineer will perform all activities in an efficient and competent manner with due regard to safety and quality, while ensuring a positive team environment.

Duties

•    Coordination of the preparation for audits, including but not limited to
• a.    Scheduling audits
• b.    Onsite audit preparation (booking rooms, audit preparation etc)
• c.    Running backroom/front-room as appropriate
•    Coordination of corrective actions, compiling and issuing response letters 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
•    Supervision and talent development of Quality Engineers and Technicians with focus on compliance, issue prevention, problem solving, and team working ethic as required.  
•    Manage performance expectations for Quality Engineers and Technicians and drive accountability as required.
•    Manage the technical quality aspects for area of responsibility and work closely with the operations team to achieve all key department metrics.
•    Ensure key quality metrics such as CAPA management, Right First Time, Complaints etc are consistently achieved.
•    Ensure thorough investigation of Quality issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrance.
•    Maintain compliance of the QMS to applicable corporate, quality and regulatory standards.
•    Participate in the review of quality trends, identify opportunities for continuous improvement and complete improvement projects using OpEx tools.
•    Participate in and support the internal and external audit programmes.
•    Support the successful validation and qualification of process and raw material changes.
•    Support introduction of new products into the site as per the required standards.
•    Maintain strong communication with internal and external stakeholders.
•    Liaise with vendors and customers on quality related issues, internal and external.
•    Adhere to all company EHS guidelines and Quality procedures.
•    Additional duties as required.

Who You Are

• B.Sc. in an appropriate Science/Quality Assurance discipline or equivalent
• 3-5 years Quality Assurance Engineering experience  
• 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
• Thorough, practical and persistent self-starter with strong motivation
• Effective time-management skills to meet deadlines
• Good problem-solving skills

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!