Sr. Quality Engineer

Danaher•New Brighton, MN

3d•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Radiometer, 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. At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're a team that celebrates diverse ideas and continuous improvement. Here, you'll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. Learn about the Danaher Business System which makes everything possible. The Sr. Quality Engineer is responsible for assuring the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. In addition, driving quality related improvement projects through cross functional teamwork in the assigned Value Stream. This position reports to the Sr. Manager, Quality Engineering and is part of the Quality Assurance and Regulatory Affairs team located in New Brighton, Minnesota and will be an on-site role. In this role, you will have the opportunity to: Lead value stream specific quality tasks, including change control, training, non-conformance, and CAPA closure. Conduct quality data analysis, trending, root cause investigation, and implementation of countermeasures. Work with manufacturing associates, R D, Engineering, and other partners on projects relating to quality and reliability, including manufacturing documentation Own QMS SOPs related to CAPA, production nonconformances, planned deviations and complaint investigations. Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.

Requirements

5+ years of manufacturing experience in an FDA regulated or ISO certified industry
In depth knowledge of QMS processes related to CAPA, nonconformance management, planned deviations, and complaint investigations.
Practical knowledge of risk management processes, statistical data analysis, and change control
Bachelor's degree in engineering, sciences or relevant work experience
Up to 10% may be required including international travel

Nice To Haves

Assembly and testing of thick film sensors for use in blood gas analysis
Statistical Software Knowledge, JMP

Responsibilities

Lead value stream specific quality tasks, including change control, training, non-conformance, and CAPA closure.
Conduct quality data analysis, trending, root cause investigation, and implementation of countermeasures.
Work with manufacturing associates, R D, Engineering, and other partners on projects relating to quality and reliability, including manufacturing documentation
Own QMS SOPs related to CAPA, production nonconformances, planned deviations and complaint investigations.
Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.

Benefits

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
Whether it's a health care program or paid time off, our programs contribute to life beyond the job.
Check out our benefits at Danaher Benefits Info .
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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