As a Senior Quality Engineer at Cytiva, you'll play a pivotal role in ensuring quality management systems (QMS) are effectively implemented. You'll collaborate with various stakeholders, act as a subject matter expert in change management, and contribute to life-saving innovations in biotechnology.
Key Responsibilities
Act as a subject matter expert for Change Management/Change Control process
Establish and maintain site/business unit level processes
Collaborate with stakeholders across several business functions
Lead or support quality and compliance projects as needed
Required Qualifications
Bachelor’s degree
At least 8 years relevant industry experience (e.g. GMP medical device, pharmaceutical)
At least 5 years relevant QMS experience dealing with investigations, CAPA, change control, risk management
Extensive experience with cGMP and/or ISO 13485
Excellent verbal, written, and presentation skills
Preferred Qualifications
Experience with supporting change control systems (ECR / ECO)
Experience with risk management (FMEA)
Analyzing and processing data with statistical tools
Working with cross-functional teams
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)