Document & Change Control Specialist

About the Role:

We are seeking a proactive and detail-driven Document & Change Control Specialist to serve as the process owner for document control, change management, and training management within our Quality Management System (QMS). This role is responsible for driving compliant and efficient workflows, ensuring documents and changes meet regulatory requirements, and enabling cross-functional teams to operate effectively within the QMS. The ideal candidate combines strong organizational skills with critical thinking and a solid foundation in quality systems, applying judgement to resolve issues, streamline processes, and maintain alignment with business needs. While this role includes day-to-day activities such as document formatting, workflow routing, and system administration, its true focus is on owning and continuously improving the processes that ensure quality, compliance and efficiency.

Location: Fulltime onsite at our Littleton, CO facility.

What's In It For You!

• Competitive Pay: $70,000-$80,000 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 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 We Are Looking For:

• Own and manage document control, change management, and training management processes within the eQMS, ensuring compliance with ISO 13485, FDA 21CFR 820, MDR, and AS9100.
• Drive workflows by routing, reviewing, and approving documents and change orders for accuracy, completeness, formatting, and compliance with company standards.
• Apply critical thinking to challenge justifications, identify gaps, and ensure changes are effective, appropriate, and properly documented.
• Partner with cross-functional teams (Quality, Regulatory, Engineering, Operations, etc.) to ensure timely and accurate execution of document and change control activities.
• Train and guide employees on eQMS best practices, including document submission, workflow routing and training assignments.
• Continuously improve document, change, and training processes by identifying inefficiencies, recommending improvements, and implementing solutions.
• Perform daily activities such as formatting, document release, workflow monitoring, while keeping focus on long-term process health and compliance
• Serve as the audit backroom lead, overseeing document retrieval, coordinating response teams, and ensuring auditors receive accurate and timely evidence of compliance.
• Lead the training management program, partnering with managers and subject matter experts to assign training and develop effective team OJTs that build capability across the organization.
• Act as subject matter expert and go-to resource for all document, change, and training management related questions.

What You Will Bring:

Education and Experience Requirements:

• Bachelor's degree required (Quality, Engineering, Life Sciences, or related field preferred) or equivalent years of experience
• 2-3 years of experience in document control, change management, and/or training management within a regulated industry (medical device, aerospace, pharmaceutical, etc.)
• Solid understanding of quality system regulations and standards (ISO 13485, FDA 21CFR Part 820, AS9100)
• Experience serving as a process owner or subject matter expert in QMS processes, within proven success in driving improvements
• Demonstrated ability to apply critical thinking and judgment when reviewing change orders, ensuring compliance and resolving gaps
• Strong organizational skills and meticulous attention to detail while managing multiple priorities
• Strong working knowledge in Microsoft Office (Word, Excel, Visio, PowerPoint)
• Strong technical writing and editing skills, with the ability to ensure clarity, accuracy, and consistency in controlled documents and change orders
• Strong interpersonal and communication skills, with the ability to influence and collaborate effectively across departments

Preferred Experience:

• Experience working in a regulated industry such as medical device, aerospace or pharmaceutical
• Hands-on experience with eQMS platforms and electronic document/workflow management systems
• Skilled in audit readiness and support, with experience leading backroom activities or equivalent
• Familiarity with quality system standards and regulations (ISO 13485, FDA 21 CFR Part 820, MDR, or AS9100)
• Knowledge of Good Documentation Practices (GDP) and document control principles within a regulated environment

Applications accepted online through (date)

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