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Cytiva · 2 days ago
Senior Quality Assurance Engineer
Westborough, MA
Full-time
Hybrid
Senior Level
8+ years exp
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Responsibilities
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
Qualification
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Required
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)
Preferred
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
Benefits
Hybrid work arrangement
Company
Cytiva
Cytiva, now with the life sciences business from Pall Corporation, is a global biotechnology leader dedicated to helping customers discover and commercialize the next generation of therapeutics.
10,001+ employees
Funding
Current Stage
Late StageLeadership Team
Ross Gold
Director, Technical Services, Vanrx
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