Senior Specialist Commercial Quality and Regulatory Affairs (w / m / d)

Beckman Coulter Diagnostics; Düsseldorf; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global leader in clinical diagnostics is seeking a Senior Specialist - Commercial QRA. This role involves maintaining ISO 9001 systems and driving compliance in the Germany, Austria & Netherlands region. The ideal candidate holds a degree in Science and has proven experience in managing quality systems. Join a team dedicated to scientific impact and patient health.

Qualifikationen

• Lead Auditor certification (ISO 9001) is required.
• Proven experience in quality management systems.
• Ability to travel for up to 20%.

Aufgaben

• Maintain and improve QMS processes for compliance.
• Monitor and report on key metrics for Quality System.
• Drive achievement of Commercial QRA objectives.

Kenntnisse

Managing a certified ISO 9001 Quality Management System

Strong knowledge of IVDR and environmental regulations

Managing ambiguity and influencing without authority

Ausbildung

University degree in Science or equivalent

Jobbeschreibung

Overview

Bring more to life.

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

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.

Learn about the Danaher Business System which makes everything possible.

Reporting to the Senior Manager - Commercial QRA for Northern Europe, the Senior Specialist – Commercial QRA, Germany, Austria & the Netherlands is responsible for all Q&RA and Environmental activities to support regional commercial operations for the Danaher Diagnostics platform.

Responsibilities

In this role, you will have the opportunity to :

• Maintain, implement, and continuously improve QMS processes and infrastructure to ensure best-in-class compliance and strong business support for the Commercial organization.
• Develop, monitor, and report on key metrics to measure the performance of the Quality System.
• Drive the successful achievement of Commercial QRA objectives and provide regular updates on progress.
• Support the development and execution of Commercial Operations objectives for the region.
• Provide input into the EU Commercial QRA budget planning process.

Qualifications

• University degree in Science or equivalent.
• Lead Auditor certification (ISO 9001).
• Proven experience managing a certified ISO 9001 Quality Management System.
• Strong knowledge of IVDR, environmental, and related regulations.
• Demonstrated ability to manage ambiguity, influence without authority, and drive results within a global, multi-cultural, matrixed organization.
• Travel, Motor Vehicle Record & Physical / Environment Requirements: Ability to travel for up to 20%.

Preferred qualifications

• Proficiency in additional European languages such as German or Dutch (in addition to English).
• Experience collaborating with external stakeholders such as regulatory authorities, notified bodies, or industry associations.
• Hands-on experience leading or influencing without authority or supporting continuous improvement initiatives (e.g., Lean, Six Sigma, or DBS tools).

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.

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