Senior Software Quality & Validation Engineer

Description

What We Are Looking For 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 TIR 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.

Onsite This role has an onsite work schedule requiring the person to be in the onsite location 5 days a week.

What’s In It For You! Competitive Pay: $75,000 - $95,000 per year. 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 13 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 You Will DoOwn 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 TIR
80002:2017, 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

Note:

This role focuses on software validation, quality systems, and regulatory compliance. It does not involve software development or coding.

Qualifications What You Will Bring

Education and Experience 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

Required Skills/Abilities Strong knowledge of software…