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Computer System Validation Senior Analyst at Stryker - ApplyBlast

Computer System Validation Senior Analyst

Stryker

4 months ago

4.0 on Glassdoor

Costa Rica

Hybrid

Full Time

Senior

0 applicants

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About this role

The FDA Computer System Validation (CSV) Lead ensures compliance with FDA regulations and industry guidelines for computer systems used in regulated product development and manufacturing. This role involves overseeing the end-to-end validation lifecycle, collaborating with cross-functional teams on strategies and documentation, and driving continuous improvement of validation programs. The position requires strong expertise in risk assessments, testing protocols, and regulatory standards to support audits and inspections.

Responsibilities

Lead end-to-end Computer System Validation lifecycle activities
Develop and maintain validation plans, protocols, and reports
Ensure compliance with FDA regulations and industry standards
Conduct risk assessments and impact analyses for critical systems
Provide subject matter expertise and training on validation best practices

Skills

Qualifications

Bachelor's degree in Computer Science or Engineering

About Stryker

stryker.com

Headquarters

Portage, Michigan, United States

Company Size

10001+ employees

Founded

1941

View Profile

Stryker is a global medical technology company that develops and sells a broad range of medical devices, equipment, and services. The company serves healthcare markets across the Americas, Asia Pacific, Europe, and the Middle East & Africa. Stryker's products span areas including surgical equipment, orthopedics, and medical instruments.