Global Vigilance Manager at Beckman Coulter Diagnostics in Chaska, Minnesota

Job Description:

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 Manager Post Market Vigilance (Post Market Quality) for Beckman Coulter Diagnostics is responsible for the following:

• Oversee the Adverse Event (Vigilance Report) process for all Beckman Coulter product lines globally; maintaining timely Adverse Event reporting as required per appropriate global regulatory agencies. Liaise and collaborate with key stakeholders and leadership teams in activities required for adverse event review and agency reporting.


• Manage team of associates responsible for Adverse Event Reporting and complaint review providing job appraisal and feedback as appropriate. Ensure team has appropriate training assigned and timely completion. Drive completion of department's and individual contributor's objectives.


• Recommend and support changes and process improvements to drive process efficiencies within the CHU to drive improvements throughout the complaint process.


• Collaborate with cross-functional teams to drive to root causes and identify countermeasures. Sustain countermeasures as appropriate.


• Maintain professional and technical knowledge by reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, and participating in professional societies associated with complaint handling, adverse event reporting and vigilance reporting.

This position is part of the Post Market Surveillance (PMS) team and is an onsite position in Chaska, MN. Within the PMS, our vision is to ensure that customer needs and expectations are met in a timely manner and compliantly.

You will be a part of the Diagnostic Global CHU team and report to the Director of Post Market Quality Assurance responsible for maintaining the Adverse Event (Vigilance Report) process and associated activities. If you thrive in a multifunctional, leadership, fast paced, supporting role and want to work to build a world-class CHU organization-read on.

In this role, you may also have the following opportunities:

• Complete necessary documentation for regulatory reports and inquiries for submission to the FDA and other global regulatory agencies.


• Own CAPA requests and/or CAPA Investigations


• Report and/or present Adverse Event (Vigilance Report) metrics


• Represent the company as subject matter expert (SME) during regulatory audits.

The essential requirements of the job include:

• Degree in Science or Engineering or equivalent.


• Experience in a similar technical/quality environment. (9 years with Bachelors degree or 7 years with Masters degree)


• Good knowledge of FDA, QSR and ISO13485 requirements.


• Good troubleshooting experience.

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

• 
  People management experience an advantage


• Knowledge of Beckman products an advantage


• Audit management experience


• Experience submitting MDRs and MIRs

Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

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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
.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.