Quality Manager - Compliance and Supplier Quality

Posted 20 Feb 2024

Carrigtwohill, Cork - Ireland

Req Id 272238

 

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.

 


 

Reporting to the Head of Quality, the Quality Manager – Compliance and Supplier Quality is a key member of the Quality Management team with responsibility for maintaining quality systems and product conformance to applicable standards and regulatory requirements.

 

The Quality Manager – Compliance and Supplier Quality will perform all activities in an efficient and competent manner, with due regard for Safety and Quality, while promoting a positive team environment and a focus on continuous improvement.

 

The Role:

 

Key Responsibilities:

 

  • Support and develop Quality colleagues in the Compliance and Supplier Quality teams, fostering a positive team environment through open communication and feedback.
  • Ensure quality system and product compliance with relevant corporate procedures, quality standards & regulations, i.e. ISO 13485, ISO 9001, MDSAP, MDD, MDR/IVDR, as applicable.
  • Responsible for execution of the Medical Device Regulation project for Class IIa Medical Devices.
  • Ensure sustaining of Medical Device and IVD product lifecycles through Design Assurance process.
  • Act as delegate Management Representative in the absence of the Head of Quality.
  • Collaborate with Regulatory Affairs and Marketing to support regulatory submissions for IVDs and Medical Devices in new/emerging markets.
  • Oversee the Quality Management system to ensure effective use, compliance and continuous improvement.
  • Responsible for Regulatory, Internal and Customer audit programmes.
  • Responsible for Supplier Quality programmes to ensure vendors are appropriately managed.
  • Implement quality and safety improvement initiatives in the Compliance and Supplier Quality teams and foster a culture of continuous improvement.
  • Facilitate quality review meetings to support the delivery of key site metrics and improvements.
  • Maintain communication with corporate and divisional personnel.
  • Responsible for ensuring compliance with all applicable Environmental, Health and Safety legislation & adherence to procedures for areas of responsibility.

 

Who you are:

 

  • BSc qualified in an appropriate scientific discipline with significant relevant experience in Medical Device/Pharmaceutical industry.
  • Strong communication, collaboration and leadership skills;
  • Proven capability in project management.
  • Good decision making and 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 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!

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