Senior Computer Systems Validation; CSV Specialist

Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.

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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.

#LI-CW1

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
• Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
• 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!

KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

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 acondition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to askhow credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.