Quality Assurance Engineer

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 Quality Assurance Engineer (Design & Manufacturing) is responsible for providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis and CAPA initiatives, ensuring timely resolution of nonconformances to maintain product quality and customer satisfaction; overseeing manufacturing validation (IQ, OQ, PQ) and design assurance activities to support effective design transfers and product launches.

This position reports to the QA Senior Manager Site Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will be an on-site role.

What you will do:

• Review and approve change control documentation (ECOs) to mitigate risks to product quality.
• Conduct investigations into manufacturing and design-related failures, ensuring appropriate corrective actions.
• Support disposition of non-conforming materials, leading trend analysis and quality event investigations. Perform other quality-related activities as needed, not limited to supporting audits, training initiatives, and cross-functional collaboration with supporting functions on continuous improvement projects.
• Participate in Deviation and Concession Control Boards, ensuring compliance with quality standards.
• Implement process improvement initiatives using Six Sigma, Lean Manufacturing, DBS and SPC methodologies.

Who you are:

• Bachelor’s degree in engineering, Health Sciences, or a related field.
• Minimum 5 years of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device, or pharmaceutical preferred).
• Experience with root cause analysis, CAPA management, and validation activities (IQ, OQ, PQ).
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Minitab, Visio).
• Knowledge of manufacturing processes, material properties, and product assembly within a regulated environment.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to lift, move or carry equipment up to 25lb.

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

• Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
• Proficiency with quality management systems (QMS) and tools like Veeva, SAP, Oracle, Magic.
• Certification in Six Sigma, Lean Manufacturing, or ASQ (CQE, CQA, or equivalent).

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.

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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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.