Senior Software Quality & Validation Engineer

3D Systems • Littleton, CO

1d • Onsite

About The Position

The Software Quality Engineer leads global ownership and continuous improvement of the software validation process for Production Quality System Software (PQSS) within Quality and manufacturing environments. This role ensures validation activities comply with FDA, ISO 13485, AS9100, and ISO TIR80002-2017 requirements. As the global SME and process owner, this individual establishes and enhances risk-based validation procedures and lifecycle controls, partnering cross-functionally with Quality, IT, Manufacturing, and system owners across multiple sites to maintain compliance and validated system integrity.

Requirements

• Bachelor's degree in Engineering, Quality, Regulatory, Computer Science, Information Systems, or related
• 4+ years of work experience in software quality engineering
• Minimum 4 years of experience in software quality, software validation, or computer system validation in a regulated industry
• Strong knowledge of software validation principles for Production & Quality System Software in regulated industries
• Working knowledge of FDA 21 CFR Part 820 and Part 11, ISO 13485, AS9100, and/or ISO TIR80002:2017
• Experience in owning, improving, or leading software validation processes
• Understanding risk-based validation methodologies and software lifecycle management
• Strong technical writing, problem solving and organizational skills
• Ability to lead validation efforts and influence cross-functional stakeholders
• Ability to identify process gaps and implement structured improvements

Nice To Haves

• Experience validating eQMS, ERP, MES, or manufacturing support software
• Experience in medical device, FDA, aerospace or other regulated industry
• CSQE or ISTQB certification preferred

Responsibilities

• Own and maintain the software validation process for Production Quality System Software (PQSS), including procedures, templates, and validation standards
• Evaluate and improve the software validation framework to ensure alignment with ISO TIR80002:2017, FDA regulations, ISO 13485, AS9100 and industry best practices
• Establish risk-based validation methodologies that are scalable, efficient and compliant
• Define validation strategies, including validation planning, risk assessment approach, user requirement expectations, protocol structure, and reporting requirements
• Collaborate with software and system owners to ensure validation deliverables are appropriately developed in accordance with validation requirements
• Provide guidance, support, and subject matter expertise throughout validation activities to ensure compliant execution
• Review and approve validation deliverables to ensure completeness, traceability, and compliance with established procedures
• Ensure validation requirements are properly applied to new systems, system changes, and upgrades
• Ensure software remains in a validated state through effective integration with change control
• Serve as primary quality SME for software validation for Littleton and Leuven sites

Benefits

• Competitive Pay: $75,000 - $95,000 per year
• Paid Leave (US ONLY): 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
• Talent Development programs
• Connection & Engagement Opportunities: Employee Resource Group program, Employee Recognition program, and 3D Gives Back program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior