Position Details
About this role
This role involves developing and maintaining software validation standards and processes to ensure compliance with regulatory requirements in a medical device environment.
Key Responsibilities
- Develops validation standards
- Guides software validation activities
- Ensures regulatory compliance
- Provides training on validation processes
- Monitors validation metrics
Technical Overview
Focuses on software validation in Waterfall and Agile environments, with expertise in regulatory standards such as FDA, ISO, IEC, and 21 CFR Part 11.
Ideal Candidate
The ideal candidate is a mid-level software quality engineer with 6+ years of experience in software validation, familiar with regulatory standards such as FDA and ISO. They possess strong leadership skills and expertise in validation processes within Waterfall and Agile environments.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in software validation, No familiarity with regulatory standards, Bachelor's degree not in relevant field
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