Lead Manufacturing Quality Engineer

Danaher Corporation • Westborough, MA • 3h ago

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 (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Manufacturing Quality Engineer is responsible for root cause analysis, CAPA ownership, and resolution of customer issues.

This position reports to the Lead Continuous Improvement Engineering Manager and is part of the Hollow Fiber Filtrations department located in Westborough, MA and will be an on-site role.

What you will do:

Own and execute engineering investigations for customer complaints, including root cause analysis, CAPA development, and documentation in Veeva and other QMS systems.

Partner with QA, Operations, and Product Quality Engineers (PQEs) to ensure timely and effective resolution of complaints.

Identify systemic issues and drive updates to work instructions, risk management documentation, and manufacturing procedures.

Contribute to customer-facing quality letters and reports, ensuring clarity, accuracy, and alignment with regulatory expectations.

Analyze complaint trends, aging cases, and closure rates; present findings to leadership and contribute to continuous improvement initiatives.

Who you are:

Bachelor's degree in Engineering, Life Sciences, or related technical field.

3+ years of experience in manufacturing or quality engineering within a regulated industry (e.g., medical devices, bioprocessing).

Demonstrated proficiency in Quality Management Systems (QMS)

Experience conducting and documenting CAPA investigations and complaint resolution activities.

Experience with Lean or DBS tools and methodologies for continuous improvement.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

Ability to lift, move, or carry equipment up to 50lb

It would be a plus if you also possess previous experience in:

Working in Hollow Fiber or similar membrane-based manufacturing environments

Using statistical tools for trend analysis and risk assessment

Authoring technical documentation for customer-facing quality communications.

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 (https://worklife.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

LI-NS3

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 (http://www.eeoc.gov/sites/default/files/2023-06/22-088\EEOC\KnowYourRights6.12ScreenRdr.pdf) .

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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