Quality System Specialist

Om jobbet

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Together with Danaher's 15+ other operating companies, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we've been advancing what's possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count.

The role Quality System Specialist for HemoCue is responsible for daily management of CAPA, Vigilance and Audits within RA/QA. The QS specialist ensures that procedures and activities related to these main tasks are in compliance with applicable requirements, e.g. current versions of ISO 13485, IVDR, etc.

You will be a part of the Quality System team at RAQA and report to the Manager, Quality Systems.

This position is part of the RAQA department, located at HemoCue HQ, in Ängelholm, Sweden and will be on-site. At HemoCue, our purpose is clear: advancing care, test by test, everywhere. Care is the bedrock upon which we stand. It's manifested in our devices, our people and how we interact with the world.

In this role, you will have the opportunity to:

• Ensure that procedures and activities related to the main tasks (CAPA, Vigilance and Audits) are in compliance with applicable regulatory requirements, e.g. current versions of ISO 13485, FDA QMSR and other applicable standards
• Act as CAPA Specialist, Audit Specialist and Vigilance Coordinator and handle the daily management of these processes
• Coordinate the CAPA Management Board and related actions and plan for audits through analysis of trends and quality data and ensure that internal audits and CAPAs are performed according to established processes
• Apply critical thinking and prioritize Quality and Compliance issues
• Act as a resource within the RAQA Team supporting with additional tasks based on operational needs

The essential requirements of the job include:

• University Degree in Science or Technology
• Minimum 3 years of experience from Quality and Regulatory Affairs
• Excellent understanding and in-depth knowledge of regulatory demands for Medical Device/IVDs including ISO13485, IVDR as well as relevant standards and regulations in MDSAP countries.
• English - fluent verbally and in writing, and preferable Swedish
• Experience reviewing and analyzing quality performance data to identify trends and areas of improvement

It would be a plus if you also possess previous experience in:

• Planning, execution and management of audits

Join a winning team today. Together, we'll 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.

Union contacts: Katarina Cooper, Akademikerföreningen, +46 431 481 302

For more information, visit www.danaher.com.

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Join our winning team today. Together, we'll 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.

For more information, visit www.danaher.com.