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Sr Manager Quality Assurance

Sr Manager Quality Assurance

Minnesota StaffingSaint Paul, MN, US
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Sr. Manager Quality Engineering

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Radiometer, one of Danaher's operating companies, our work saves livesand 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.

The Sr. Manager Quality Engineering is responsible for an integral leader in promoting and ensuring product and process quality throughout the organization's operations. This role combines a strong focus on day-to-day operational quality assurance with continued responsibility for select quality management system (QMS) activities and regulatory compliance. This position reports to the Director of Quality Assurance and Regulatory Affairs and is part of the Quality Assurance and Regulatory Affairs organization located in New Brighton, Minnesota and will be an on-site role. In this role, you will have the opportunity to :

  • Lead, develop, and manage the Operations QA team to ensure consistent quality practices across manufacturing, warehousing, distribution, and supply chain activities.
  • Oversee in-process quality controls, release procedures, and management of nonconforming materials.
  • Monitor and analyze operational quality metrics, identifying trends and implementing corrective or preventive actions as needed.
  • Ensure timely investigation and resolution of deviations, complaints, and CAPAs related to operational output.
  • Work closely with production and engineering to implement and sustain process improvements that enhance product quality and operational efficiency.
  • Lead audit preparation, execution, and response activities (internal and external).
  • Support ongoing QMS maintenance, with responsibility for selected QMS elements such as document control, internal audits, management reviews, and QMS training.

The essential requirements of the job include :

  • Bachelor's degree in Life Sciences, Engineering, Operations, or a related field; advanced degree preferred.
  • 8+ years of progressive experience in operations quality assurance, with exposure to QMS and regulatory affairs in regulated industries (e.g., medical device, pharmaceutical, biotech, food manufacturing).
  • Demonstrated leadership experience managing operational quality teams and cross-functional projects.
  • Strong knowledge of operational QA methodologies, nonconformance management, and process improvement tools (e.g., CAPA, Lean, Six Sigma).
  • Familiarity with ISO standards (ISO 13485, ISO 14001) and regulatory requirements (FDA, EMA, etc.).
  • Exceptional analytical, communication, and organizational skills.
  • Travel, Motor Vehicle Record & Physical / Environment Requirements : if applicable for role + Up to 20% may be required including international travel
  • 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.

    The annual salary range for this role is $120,000 - $165,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus / incentive pay. We offer comprehensive package of benefits including paid time off, medical / dental / vision insurance and 401(k) to eligible employees.

    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.

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    Manager Quality Assurance • Saint Paul, MN, US