Validation Software Engineer - Remote

Overview

The Quality Software Validation Engineer will develop and execute validations to ensure regulatory compliance to established internal and external standards related to released product or current production.

In Short

• Develop and execute validations for regulatory compliance.
• Support writing of validation protocols and reports.
• Gather and analyze data related to product quality.
• Collaborate across departments for product implementation.
• Validate equipment, processes, and software.
• Manage documentation systems and validation records.
• Analyze quality metrics and identify trends.
• Understand and follow current Good Manufacturing Practices (cGMP).
• Investigate quality issues and implement corrective actions.
• Lead internal projects for new product introductions.

Requirements

• Bachelor's degree in an engineering discipline.
• 6-10 years of software validation experience.
• Experience in medical device or FDA-regulated industries.
• Knowledge of FDA Quality System Regulations (QSR).
• Proficient in technical writing and Microsoft Office.
• Bonus: Experience in computer programming or graphic design.

Benefits

• Supportive work environment for learning and growth.
• Opportunity to contribute to meaningful health solutions.
• Culture that values opinions and contributions.
• Flexibility and work-life balance.