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Danaher Corporation Manager Quality Assurance Post Market Quality in Chaska, Minnesota

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.

This position is part of the Complaint Handling Unit (CHU) located in Marseille/ Chaska and will be hybrid. Within the CHU, our vision is to ensure that customer needs and expectations are met in a timely manner and compliantly.

You will be an integral part of the Diagnostic Global CHU team and report to the Senior Manager Post Market Quality Assurance responsible for maintaining the global complaint handling 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 will have the opportunity to:

  • Manage the complaint handling process for the Immunoassay product lines

  • Oversee department objective assignments, investigations, and long-term tasks

  • Collaborate with key stakeholders and site leadership teams to ensure product issues and malfunctions are corrected in a timely manner

  • Liaise with Corporate RA & Subcommittees in activities required for adverse event review and agency reporting

  • Recommend changes, process improvements

  • Lead and support strategic process improvement projects to drive efficiencies within CHU

  • Mentor team members through escalations within the Quality Management System

  • Provide support for Prague & Suzhou facilities

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

  • Perform data analyses and data management including internal and external reporting and complaint data trending to ensure that product safety and performance analyses are data driven and scientifically sound.

The essential requirements of the job include:

  • Bachelor’s degree in science or engineering with 9 years of relevant experience Or Master’s Degree in same and 7 years of experience

  • Strong working knowledge of FDA, QSR and ISO13485 requirements

  • Excellent problem solving and troubleshooting experience

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

  • People management experience

  • Knowledge of Beckman Immunoassay products

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.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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 (https://www.dol.gov/agencies/ofccp/posters) .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. If you’ve ever wondered what’s within you, there’s no better time to find out.