Join Cytiva as a Senior Quality Engineer to enhance quality management systems in the life sciences sector. You will lead initiatives impacting human health while collaborating across various teams to ensure compliance and continuous improvement.
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 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
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 and facilitating teams to identify and implement solutions
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)