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Danaher Corporation Quality Assurance Manager in Minneapolis, Minnesota

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer 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.

Would you love to manage the quality engineering function of the assigned Value Stream and manage document control, final release, NCR, CAPA and MVFs within the Quality organization? You will define and implement quality assurance in support of the quality goals for Radiometer. Actively participate in production team activities to ensure that the manufacturing and quality processes conform to FDA regulations, ISO standards and internal requirements. Serve as a Quality Assurance resource for manufacturing to identify non-compliance areas and report trends as well as improve process capability, reliability and the quality of products and processes. Manage the QA Associate and Quality Engineer, provide guidance on best practices and use the Danaher Business System (DBS) to improve efficiency of these processes.

Ensure the promotion and awareness of regulatory and customer requirements throughout the organization. Provide leadership and direction for document control and manufacturing operations. Recommend programs to improve manufacturing quality and throughput. Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.

Responsibilities

  • Manage and develop the current staff of 2 people

  • Hire and train new staff

  • Act as senior site quality lead

  • Support manufacturing

  • Support external audits

Qualifications

  • BS in Engineering, Science or equivalent

  • 7+ years of quality assurance experience in the medical device industry

  • 2+ years in a management role

  • Be willing and able to contribute as an individual contributor

Preferred Qualifications

  • Validation experience

  • External audit experience (FDA or Notified Body)

  • 6Sigma Blackbelt

#LI-SM1

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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.

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