What are the responsibilities and job description for the Sr. Computer Systems Validation Specialist position at KARL STORZ ENDOSCOPY?
KARL STORZ is currently seeking an experienced Senior Computer Systems Validation (CSV) Specialist to lead our global non-device software validation process, ensuring compliance with regulatory requirements and industry standards. This role will be responsible for collaborating with cross-functional teams, managing validation projects, and providing technical expertise to ensure timely delivery of software system solutions.
Key Responsibilities :
- Manage and support all U.S. non-device software validation activities for manufacturing and distribution sites
- Develop and implement CSV workflows, analyze system solutions and support validation protocols, reports and other applicable documentation
- Assure validation activities are conducted in a compliant and timely manner
- Evaluate and audit software documentation and processes
- Provide guidance and recommendations to software users on qualification / validation requirements
- Collaborate with stakeholders to validate system solutions
- Develop and manage validation documentation and databases
- Lead risk assessments and analyze validation test data
- Identify and mitigate software validation gaps
- Remains current on new and emerging best practices for software validation
Requirements :
Physical Requirements :
Preferred Qualifications :
Who we are :
KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region.For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and operating room integration to benefit patients and healthcare providers alike.
With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create-it's about the lives we change, together.
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