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. Collaborate with cross-functional teams, manage validation projects, and provide 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:
- 7+ years of CSV experience with at least 5 years experience in a regulated industry (medical device, auto, aerospace manufacturing QMS environment)
- Associate’s degree in Applied Science (or relevant certificates with proven experience)
- Proficiency in regulatory and quality regulations (ISO 13485:2016, FDA 21 CFR 820, FDA 21 CFR Part 11)
- Subject matter expert of software validation industry standards and current regulatory environment to provide technical guidance and expertise related to regulatory compliance.
- Experience in managing validation projects.
- Able to prepare written reports and give presentations to all levels of the organization
- Strong technical writing and computer skills
- Excellent communication, leadership, and problem-solving abilities
- Abiity to travel up to 10%
Physical Requirements:
- Ability to lift up to 20 lbs on occasion
- Ability to stand and walk for periods of time when participating in audits
Preferred Qualifications:
- 8+ years of CSV experience with progressive responsibility managing CSV activities
- Bachelor's degree in software engineering, computer science, IT, or data science
- Experience in validation activities in medical device industry, specifically meeting FDA 21 CFR Part 11 compliance
- Excellent technical skills and project management abilities
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 createit’s about the lives we change, together.
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