Senior Computer Systems Validation (CSV) Specialist
KARL STORZMassachusetts, United States ⢠California, United States
Posted March 24, 2026
Full Time
About the Company
KARL STORZ advances medical progress through innovative endoscopic solutions with a mission to improve human and veterinary surgical specialties.
Job Description
Join a global leader in medical technology as a Senior Computer Systems Validation (CSV) Specialist. Lead and manage non-device software validation activities, ensuring compliance with regulatory requirements. Collaborate with global teams to drive best-in-class validation practices.
Requirements
- 7+ years of CSV experience in a regulated industry
- Associate degree in Applied Science or equivalent experience/certifications
- Strong knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11
- Expertise in software validation standards, technical writing, and documentation control
- Experience managing validation projects and collaborating across technical and business teams
- Exceptional organizational, communication, and technical writing skills
Benefits
- Competitive benefits
- Stability
- Opportunity to influence global processes
