Software Quality Engineer

3D Systems • Littleton, CO

3d • $76,000 - $100,000

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

• 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 TIR80002-2:2017
• 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
• Bachelor's degree in Engineering, Quality, Regulatory, Computer Science, Information Systems, or related 4+ years of work experience in software quality engineering
• Minimum 3-5 years of experience in software quality, software validation, or computer system validation in a regulated industry

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
• Medical device experience is a plus

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: $76,000-$100,000 annual salary. Our employees are the best part of our company. We want you to feel valued, appreciated, and included. Because of this, we make sure your hard work is recognized.
• 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. Yep, you read that correctly. We are a Company that values you and makes sure you take time for yourself.
• 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.
• Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence across more than 15 countries worldwide. Experience a workplace comprised of talented individuals who are passionate about serving our customers and each other.
• Innovative Culture: Innovation is at the heart of what we do! Since our founding in 1986 by Chuck Hull, the inventor of 3D printing, we have continuously pushed the boundaries of what is possible with additive manufacturing. When you join 3D, you will have the opportunity to work with cutting edge technology in an innovative and collaborative culture!
• Talent Development: At 3D Systems, we invest in talent programs to support employees with opportunities to grow, contribute, develop, and thrive in their careers.
• Connection & Engagement Opportunities: We strive to cultivate an environment where our diverse global workforce can connect and thrive. Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program, are just a few examples of how you will be empowered to build connections, celebrate wins, and make a meaningful impact.

What This Job Offers

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