Senior Quality Assurance Engineer

1 month ago


Westborough, Massachusetts, United States Danaher Full time
Join our team as a Senior Quality Assurance Engineer at Cytiva

Are you passionate about ensuring quality in the biotechnology industry? Cytiva is looking for a dedicated Senior QA Engineer to join our Quality Assurance team in Westborough, MA. You will play a key role in managing various aspects of the Quality Management System, including complaints, non-conformances, CAPAs, field actions, and change control.

Key Responsibilities:
  • Lead a Complaint Handling Unit (CHU) and manage Complaint Defect Tracking and Resolution (CDT&R) for products
  • Provide guidance on Containment Actions, Root Cause Analysis, and Corrective Action Plans
  • Manage Field Actions and facilitate risk-assessment activities
  • Generate metrics for quality related activities
  • Support process improvement strategies and continuous improvement projects
Requirements:
  • Bachelor's degree required; additional training/education preferred
  • Minimum 8 years of relevant industry experience
  • Experience in post-market surveillance and QA activities
  • Knowledge of cGMP and ISO 13485 standards
  • Excellent communication skills in English
Additional Preferred Experience:
  • Change control systems support
  • Data analysis with statistical tools
  • Working with cross-functional teams to implement solutions
Cytiva offers a hybrid work arrangement, providing flexibility and career advancement opportunities. Join us in our mission to advance future therapeutics from discovery to delivery. Discover the impact you can make at Cytiva

At Cytiva, we are dedicated to building a diverse and inclusive workforce. We value the unique perspectives and contributions of all individuals. Join us in shaping the future of biotechnology and making a difference in global healthcare. Learn more about our work at our website.

Cytiva is part of Danaher Corporation, a global leader in science and technology. We are committed to equal opportunity and diversity in the workplace. Join us in accelerating the impact of tomorrow's science and technology

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