Global Software Validation Lead - QA Compliance

3D Systems Corporation; Littleton (CO); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive Pay

Paid Leave

401(k)

Health & Wellness

Global Team

Innovative Culture

Talent Development

ENGAGEMENT PROGRAMS

Job summary

3D Systems Corporation in Littleton seeks a Software Quality Engineer to lead 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.

You will establish risk-based validation methodologies, define validation strategies, and collaborate across Quality, IT, Manufacturing, and system

Qualifications

• Bachelor's degree in Engineering, Quality, Regulatory, Computer Science, Information Systems, or related field.
• Minimum 4 years of work experience in software quality engineering in a regulated industry.

Responsibilities

• Own and maintain the software validation process for PQSS.
• Evaluate and improve the software validation framework to align with regulatory standards.
• Establish risk-based validation methodologies that are scalable and compliant.
• Define validation strategies, planning, and reporting requirements.
• Collaborate with software and system owners to ensure validation deliverables meet requirements.
• Lead validation efforts and provide SME guidance across sites.

Skills

Software validation

Regulatory compliance

Technical writing

Cross-functional collaboration

Problem solving

Quality systems

Education

Bachelor's degree in Engineering/Quality/Regulatory/CS/IS

Tools

eQMS

ERP

MES

Job description

3D Systems Corporation in Littleton seeks a Software Quality Engineer to lead 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.

You will establish risk-based validation methodologies, define validation strategies, and collaborate across Quality, IT, Manufacturing, and system