Sr Manager Quality Assurance

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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. Were a team that celebrates diverse ideas and continuous improvement. Here youll 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. Manager Quality Engineering is responsible for an integral leader in promoting and ensuring product and process quality throughout the organizations 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:

• Bachelors 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 its 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 $12000 - $165000. 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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .