Job Description
Position: Computer Systems Validation Specialist
Responsibilities:
- Follow ADC quality system procedures for non-product computer systems validation, primarily SaaS validation.
- Manage projects, conduct risk assessments, define requirements, perform testing, and maintain all relevant documentation.
- Collaborate with system owners, subject matter experts, and quality approvers.
Requirements
- Significant experience in medical device computer systems validation, including SaaS, in compliance with FDA requirements.
- Experience with validation of 21 CFR Part 11 requirements.
Job Details
- Job Type: Contract
- Salary: $55.00 – $65.00 per hour
- Experience level: 5 years
- Schedule: 8-hour shift
- Work setting: Remote
Educational Qualifications
Bachelor’s degree (Preferred)
Experience
- ADC quality system procedures: 5 years (Preferred)
- Medical device computer systems validation: 5 years (Preferred)
- Validation of 21 CFR Part 11: 5 years (Preferred)
Work Location
Remote
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