Global Software QA & Validation Lead

Morgan Stanley; Littleton (CO); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive Pay

Paid Leave

401(k)

Health Plans

Global Team

Innovative Culture

Talent Development

Engagement Opportunities

Job summary

3D Systems is seeking a Senior Software Quality & Validation Engineer to lead PQSS validation, ensuring regulatory compliance and lifecycle control across sites. You will own procedures, risk-based methods, and cross-functional collaboration with Quality, IT, and Manufacturing.

The role is onsite in Littleton, CO, requiring five days on site. Experience in regulated industries and strong technical writing are essential for success in this critical quality function.

Qualifications

• Strong knowledge of software validation principles for regulated environments.
• Experience owning or leading software validation processes.
• Understanding risk-based validation methodologies and lifecycle management.
• Excellent technical writing and documentation skills.

Responsibilities

• Own and maintain the software validation process for PQSS, including procedures and standards.
• Evaluate and improve the software validation framework to align with regulatory requirements.
• Establish scalable risk-based validation methodologies and lifecycle controls.
• Define validation strategies, planning, and reporting requirements.
• Collaborate with software/system owners to ensure compliant validation deliverables.
• Provide SME guidance throughout validation activities.
• Review and approve validation deliverables for traceability and compliance.
• Ensure validation applies to new systems, changes, and upgrades.
• Maintain validated state through change control integration.
• Serve as primary quality SME for Littleton and Leuven sites.

Skills

Software validation

Regulatory compliance

Quality systems

Technical writing

Cross-functional collaboration

Risk-based validation

Lifecycle management

Education

Bachelor's degree

Job description

3D Systems is seeking a Senior Software Quality & Validation Engineer to lead PQSS validation, ensuring regulatory compliance and lifecycle control across sites. You will own procedures, risk-based methods, and cross-functional collaboration with Quality, IT, and Manufacturing.

The role is onsite in Littleton, CO, requiring five days on site. Experience in regulated industries and strong technical writing are essential for success in this critical quality function.