Senior Quality Assurance Engineer

4 weeks ago

Westborough, Massachusetts, United States Danaher Full time

Be part of something altogether life-changing

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. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Senior Quality Assurance Engineer for Cytiva is responsible for various aspects of the QMS, including complaints, non-conformances, CAPAs, field actions, and change control.

This position is part of the Quality Assurance team located in Westborough, MA and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

  • Lead a Complaint Handling Unit (CHU) and manage Complaint Defect Tracking and Resolution (CDT&R) for products. Tasks include analyzing trends, tracking major issues and related corrective actions, triaging, coordinating and supporting investigations, writing and reviewing technical reports for customer, and interfacing with customers in various forms of communications.
  • Provide guidance to other cross-functional departments on Containment Actions, Root Cause Analysis, Investigation Activities, and Corrective Action Plans for internal non-conformances. Review and approve Investigations and CAPAs owned by other departments.
  • Manage Field Actions and facilitate risk-assessment activities
  • Generate NC/CAPA/Complaint/Field Action Metrics for the site
  • Develop process improvement strategies and support execution of site/team continuous improvement goals and projects

The essential requirements of the job include:

  • Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or Master's level program
  • At least 8 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required
  • At least 3 years relevant experience dealing with post market surveillance and QA activities (complaint triage, investigations, CAPA, etc.) required; 4-6 years preferred
  • Extensive experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance
  • Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing)

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

  • Experience with supporting change control systems (ECR / ECO)
  • Analyzing and processing data with various statistical tools, and drawing relevant conclusions
  • Working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

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 to request accommodation.

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