Role OverviewThe Senior Software Validation Quality Engineer is responsible for supporting and maintaining the organization's software validation and Computerized Systems Assurance (CSA) program within a regulated medical device environment.
What You Will Do
Maintain and continuously improve the software validation and Computerized Systems Assurance (CSA) program, provide guidance on software risk assessments, validation impact assessments, and risk-based validation strategies.
Why It Might Be a Fit
This role requires experience in a regulated industry, familiarity with FDA quality system regulations, and strong communication, collaboration, and technical writing skills.
Requirements
- Bachelor's degree in a technical, scientific, quality, or related discipline
- 4+ years of experience in a regulated industry
- Familiarity with FDA quality system regulations, electronic records requirements, and/or quality management system standards
- Understanding of medical device product lifecycle processes and quality system requirements
- Experience conducting software risk assessments, validation reviews, and change impact assessments
- Experience authoring or reviewing validation plans, protocols, reports, and software risk assessments
Benefits
- Competitive Pay: $85,000 - $100,000 per year
- Paid Leave (US ONLY): Enjoy time away from work with Company paid holidays and a flexible working schedule through our paid time off (PTO) policy
- 401(k): Prepare for a secure retirement with our 401k plan, which includes an employer matching contribution
- Comprehensive Health & Wellness Plans: We want to be here for our employees throughout all stages of life, which is why we offer a wide range of resources, information, and support during your career with us
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