Cytiva is seeking a Senior Quality Engineer to enhance their quality management system, ensuring compliance and effective change control. This role offers a chance to impact life sciences and biotechnology positively while working collaboratively across teams in a culture that fosters innovation and belonging.
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
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 to identify and implement solutions
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)