Join Cytiva as a Senior Quality Engineer and be at the forefront of life sciences innovation. You'll oversee critical aspects of the Quality Management System and collaborate with cross-functional teams to ensure compliance and quality in life-saving products.
Key Responsibilities
Act as subject matter expert for Change Management/Change Control process
Establish and maintain site/business unit level processes and procedures
Collaborate with stakeholders across business functions
Lead or support quality and compliance projects
Required Qualifications
Bachelor’s degree required
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 including documentation, audit, nonconformance and CAPA
Excellent verbal, written, and presentation skills in English
Preferred Qualifications
Experience with supporting change control systems (ECR / ECO) and risk management (FMEA)
Analyzing and processing data with various statistical tools
Working with cross-functional teams to identify and implement solutions
Benefits & Perks
Comprehensive benefits package including medical/dental/vision insurance401(k)Paid time off