Senior Computer Systems Validation (CSV) Specialist
Charlton, MA, US, 01507
Senior Computer Systems Validation (CSV) Specialist
Location: Charlton, MA or Goleta (Santa Barbara), CA
Join a global leader in medical technology and help shape the future of digital quality and compliance. KARL STORZ is a family-owned, innovation‑driven organization known for advancing minimally invasive surgery and delivering world‑class endoscopy solutions for more than 80 years. With a strong culture of collaboration, integrity, and continuous improvement, KARL STORZ North America offers the opportunity to make a meaningful impact in healthcare while growing your career in a supportive, people‑first environment.
About the Role
We are seeking a Senior Computer Systems Validation (CSV) Specialist to lead and manage non‑device software validation activities across our U.S. manufacturing and distribution sites. In this highly visible role, you will collaborate with global teams, ensure compliance with regulatory requirements, and drive best‑in‑class validation practices that support our Quality Management System and operational excellence.
What You’ll Do
- Lead and manage the global CSV process for U.S. sites, partnering with cross‑functional and international teams.
- Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, and internal standards.
- Develop, review, and oversee validation lifecycle documentation, including plans, protocols, risk assessments, and reports.
- Analyze validation data, identify gaps, and support investigations and corrective actions.
- Manage vendors and consultants providing CSV services.
- Maintain validation tracking databases and contribute to process improvement initiatives.
- Represent CSV and IT during audits and regulatory inspections.
What You Bring
Required:
- 7+ years of CSV experience, including 5+ years in a regulated industry (medical device, aerospace, automotive, etc.).
- 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.
- Ability to manage multiple complex projects independently.
- Ability to travel up to 10%
Preferred:
- Bachelor’s degree in software engineering, computer science, IT, or related field.
Why KARL STORZ
- Work for a respected global medical technology leader with a strong commitment to quality and innovation.
- Join a collaborative culture that values professional growth, continuous learning, and cross‑functional teamwork.
- Contribute to solutions that directly support patient care and healthcare advancement.
- Enjoy competitive benefits, stability, and the opportunity to influence global processes.
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KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Worcester