Job Information
Danaher Corporation Quality Systems Manager in O'Callaghan Mills, Ireland
Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Quality Systems Manager for Beckman Coulter Ireland is responsible for maintenance and implementation of Quality System procedures and policies necessary for the efficient operation of the quality system in Beckman Coulter Ireland Inc.
This position is part of the European QRA Organization located just outside Tulla in Lismeehan, O'Callaghan's Mills, Co. Clare and will be based onsite. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Quality Systems team and report to the Senior Director QRA responsible for overseeing Beckman Coulter Ireland Inc Quality System activities. If you thrive in a fast paced, exciting environment and want to work to build a world-class QRA organization—read on.
In this role, you will have the opportunity to:
Become a member of the Beckman Coulter Ireland Inc. QRA leadership team, implementing strategic initiatives to improve products and processes.
Manage the BCII QSMR process (Quality System Management Review) and BCII objective tracking process to include ongoing review.
Be responsible for the maintenance and implementation of Quality System procedures and policies necessary for the efficient operation of the quality system, ensuring their compliance with regulatory and corporate requirements as well as industry best practices.
Lead a team of Quality Systems professionals in Ireland and abroad, and take on the lead Role in external audits. Ensure site is in a state of audit-readiness. Act as Deputy Management Representative.
Manage the BCII CAPA (corrective and preventive action) system, including as necessary personnel training/mentoring on the CAPA process.
Maintain a strong on-going knowledge via reading as well as class room training where applicable of latest agency regulatory requirements (e.g. US FDA, China FDA, Health Canada) and applicable standard requirements (e.g. ISO 13485)
The essential requirements of the job include:
Bachelor Degree in a Science or Engineering related discipline with 9 plus years’ experience or Master’s Degree with 7 plus years’ Experience or Doctoral Degree in filed with 4 plus years’ experience.
Strong Troubleshooting skills
Strong interpersonal and communication skills
It would be a plus if you also possess previous experience in:
Experience implementing a QMS
Lead auditing qualification
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.