CAPA Manager

About the Role

Bring more to life. Are you ready to accelerate your potential and make a real difference within diagnostics? At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. 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.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

The CAPA Manager is responsible for the performance of the CAPA process and associated metrics. This position reports to the Manager Quality Assurance and is part of the Quality Assurance department located in Munich and will be an on-site role.

Responsibilities

In this role, you will have the opportunity to:

• Ensure each site supports effective CAPA implementation and continuous improvement
• Lead the CAPA Review Board to drive alignment with quality goals and expectations across the organization
• Develop and implement ongoing education programs to enhance CAPA process knowledge and execution among stakeholders
• Establish and track key performance indicators to monitor CAPA effectiveness and identify opportunities for process optimization
• Assist teams in conducting thorough root cause analyses and drafting robust CAPA plans to address identified issues
• Analyze quality monitoring data using statistical techniques to detect existing and potential causes of non-conformances and drive proactive quality measures
• Provide active support during external audits, including preparation of documentation, coordination with stakeholders, and response to auditor queries

Qualifications

The essential requirements of the job include:

• Bachelors or Master´s degree in Engineering Field (Mechanical or Electrical Engineering field or any other relevant Engineering fields)
• Multiple years of experience in Quality Management Systems
• Strong knowledge of FDA regulations, ISO 13485 and other relevant quality standards
• Excellent analytical, communication, and leadership skills
• Proficiency in statistical analysis and quality tools

About Danaher

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.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world's most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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