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QA Product Surveillance Lead

QA Product Surveillance Lead

Danaher CorporationLogan, UT, United States
5 days ago
Job type
  • Full-time
Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, 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.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System () which makes everything possible.

The QA Product Surveillance Lead will direct the Complaint Handling Unit (CHU), ensuring the timely triage, investigation, and closure of product quality complaints. This critical role supports customer satisfaction, regulatory compliance, and continuous improvement by coordinating cross-functional investigations, analyzing complaint trends, and driving corrective actions. This role will interface directly with customers, produce high-quality documentation, and serve as a Subject Matter Expert during audits and customer visits.

This position reports to the Senior Manager, Quality Assurance and is part of the Quality Assurance department located in Logan, Utah and will be an on-site role.

What you will do :

Lead Complaint Handling Unit (CHU) : Oversee triage, investigation, and closure of product complaints, ensuring timely resolution and high-quality documentation in compliance with QMS standards.

Analyze and Report Trends : Perform statistical analysis on failure modes and emerging issues across product lines; provide actionable insights and support root cause investigations and corrective actions.

Cross-Functional Collaboration & Communication : Partner with Manufacturing, Product Management, and Supplier Quality to drive robust investigations; interface with customers and author technical reports and CAPA documentation.

Support Audits and Continuous Improvement : Act as Subject Matter Expert during audits and customer visits; contribute to internal audit programs and lead process improvement initiatives aligned with quality and compliance goals.

Who you are :

Education & Experience : Bachelor's degree or equivalent industry experience (minimum 5 years) in GMP-regulated environments such as medical devices or pharmaceuticals; at least 3 years of hands-on experience in post-market surveillance, including complaint handling, investigations, and CAPA.

Technical & Regulatory Expertise : Strong knowledge of cGMP, ISO 9001 / 13485, and core QMS principles; experienced in audit readiness, documentation practices, and driving QMS improvements across cross-functional teams.

Communication & Problem Solving : Proven ability to manage competing priorities in fast-paced settings; skilled in technical writing, stakeholder communication, and facilitating collaborative problem-solving with attention to detail and quality.

Cytiva, 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 () .

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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

#LI-GC1

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's 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.

For more information, visit www.danaher.com .

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.

The U.S. EEO posters are available here () .

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 : 1-202-419-7762 or applyassistance@danaher.com .

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Qa Lead • Logan, UT, United States

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