Senior Quality Assurance Engineer
1 month ago
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
- 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
- Change control systems support
- Data analysis with statistical tools
- Working with cross-functional teams to implement solutions
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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