Join Cytiva as a Senior Quality Engineer and play a critical role in enhancing life sciences through quality management systems. You will lead initiatives in change control and collaborate across teams to ensure compliance, contributing to life-saving innovations.
Key Responsibilities
Act as a subject matter expert for Change Management/Change Control process
Establish and maintain site/business unit level processes and procedures
Collaborate with stakeholders across several business functions
Lead or support quality and compliance projects
Required Qualifications
Bachelor’s degree
At least 8 years relevant industry experience (GMP medical device, pharmaceutical)
At least 5 years relevant QMS experience (investigations, CAPA, change control, risk management)
Extensive experience with cGMP and/or ISO 13485
Excellent verbal, written, and presentation skills in English
Preferred Qualifications
Experience with supporting change control systems (ECR / ECO)
Experience with risk management (FMEA)
Analyzing and processing data with statistical tools
Experience working with cross-functional teams
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)