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

As a vital member of the Senior Leadership Team, the Head of Quality & PRRC (Person Responsible for Regulatory Compliance) is responsible and oversees the strategic direction and execution of Quality Control and Quality Assurance systems across multiple sites. This role ensures regulatory compliance, oversees Quality functions, drives a culture of proactive quality, and leads teams to embed quality across operations.  As a member of the Senior Leadership Team, the Head of Quality & PRRC contributes to, and executes, priorities and strategic initiatives for Cork Operations.

 

Key responsibilities:

 

Acts as the Management Representative with the authority and responsibility to ensure that the Quality System is implemented and maintained to applicable quality and regulatory requirements.Acts as the PRRC, as per relevant regulatory and procedural requirements, to ensure compliance to Article 15 of the EU MDR 2017/745 and Article 15 of the EU IVDR 2017/746Ensuring the operation of an effective internal audit program Chair the Management Review process ensuring that all issues relevant to maintaining the continuing suitability and effectiveness of the Quality System are reviewed at least annually.Defines and oversees the execution of the Quality strategy aligned with organizational goals.Communicates quality objectives and performance effectively to all stakeholders, including senior leadership and regulatory bodies.Ensures adherence to safety and quality regulations, specifications, and policies to enable a safe working environment and strong delivery to the customer.Promotes awareness of regulatory and customer requirements and expectations throughout the organisation.Ensures that manufacturing operations conform to quality standards, applicable Quality, Customer and Regulatory specifications.Ensures product, process and raw material specifications remain current, and that product released into inventory is in compliance with defined specifications.Liaises with government Regulatory departments & Notified Bodies to ensure compliance with standards.Fosters a collaborative, proactive quality culture to motivate teams to actively engage in identifying opportunities for improvement of quality processes.Develops and oversees risk management frameworks for risk reduction.Provides oversight and coordination of all quality activities across Cork Operations.Champions initiatives for continuous improvement in quality processes and systems.Role models coaching and mentoring across functions to develop team and individual performance.Ensures compliance with all applicable Environmental, Health and Safety legislation & adherence to procedures for areas of responsibility.

 

Who You Are:

 

B.Sc. Degree in a technical field, preferably in chemistry or microbiology.Extensive experience in quality management.Comprehensive knowledge of quality control standards and procedures, particularly in SPC, sterility, environmental control, and validation requirements.

 

To qualify as a PRRC, candidates must meet one of the following criteria per MDR and IVDR Article 15:

 

Variant 1: A diploma, certificate, or formal qualification from a university degree or recognized training course in law, medicine, pharmacy, engineering, or a relevant scientific field, along with at least one year of professional experience in regulatory issues or quality management systems related to Medical Devices.

 

Variant 2: Four years of professional experience in regulatory issues or quality management systems related to Medical Devices.

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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!