Director, Quality (Finance)

What We Are Looking For

The Quality Director will develop and enhance 3D Systems' comprehensive healthcare quality strategy while ensuring customer satisfaction and corporate goals are consistently achieved or exceeded. This role also serves the needs of industrial manufacturing and requires dynamic collaboration across Advanced Manufacturing, Personalized Health Services, Medical Devices, and the Application Innovation Group. The role partners Quality leaders, Manufacturing Engineering, Production staff for healthcare and industrial products, and our Regulatory team to promote and deliver clear alignment across the organization. You'll define an innovative quality roadmap that simultaneously improves customer satisfaction, employee engagement, and stakeholder value while serving as a transformational change agent. Join us in shaping the future of manufacturing and making a meaningful impact on additive manufacturing innovation at one of the industry's most forward-thinking companies!

Onsite

This role has an onsite work schedule requiring the person to be in the onsite location (Littleton, CO) 5 days a week.

What's in it for You!

• Competitive Pay: $162,000 - $200,000 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 offer a comprehensive benefit package that includes medical, dental and vision coverage, company-paid short-term and long-term disability insurance, as well as company-paid basic life insurance that supports you during your career with us. We believe that taking care of our employees is essential, and these benefits reflect our commitment to your health, security, and peace of mind.
• 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 You Will Do

Oversee Quality Teams at in US and Belgium:

• Lead and mentor Quality Teams across Littleton (CO), and Leuven (Belgium)
• Provide clear strategy and vision aligned with business objectives.
• Manage staffing, performance evaluations, and career development.
• Set employee objectives linked to business initiatives and key performance indicators.
• Direct quality management systems activities across all sites.
• Oversee Management Review processes, Customer Complaint Systems, and CAPA Systems for healthcare.
• Manage Training programs, Supplier Quality, and Internal Audit Systems.
• Ensure regulatory compliance.
• FDA Quality System Regulation (21 CFR Part 820) registration and inspection readiness.

o Maintain ISO 13485, ISO 9001, MDSAP (Medical Device Single Audit Program), Medical Device Regulation (MDR), AS/EN 9100 certifications.

o Other applicable ISO/EN standards based on product portfolio and regional requirements

• Support Design Control procedures for all New Product Introduction (NPI) initiatives.
• Lead the implementation and maintenance of a robust Risk Management process in accordance with ISO 14971, ensuring integration across the product lifecycle and alignment with global regulatory expectations.
• Foster high-performing teams by embracing 3D Systems' corporate values and employee engagement tools.

Lead Strategic Quality Initiatives:

• Develop and execute comprehensive quality strategy through short term and long-term business planning.
• Serve as subject matter expert for critical quality functions, specifically within the healthcare product lines.
• Lead product complaint investigations and CAPA root cause analysis.
• Oversee nonconforming materials processes and dispositions.
• Act as primary liaison for external compliance activities.
• Coordinate ISO, Regulatory, and Customer audits of Quality Management Systems.
• Support internal and external audit activities.
• Lead QMS harmonization between Leuven and Littleton and eQMS implementation across multiple sites.

Partner with Cross-Functional Teams:

• Collaborate with Engineering, Manufacturing, and R&D to ensure integrated quality approach.
• Maintain compliance through strong design control and project management understanding.
• Ensure quality, compliance, customer satisfaction, and patient safety standards.
• Drive operational excellence through shared accountability.
• Deliver on Cost of Poor Quality (COPQ) reduction and scrap minimization.
• Improve on-time delivery and drive continuous process improvements.
• Support manufacturing and component investigations while participating in designated engineering projects.

What You Will Bring

Education and Training

• Bachelor's degree, preferably in engineering or related field; or equivalent combination of education and experience.

Required Experience

• 10 years or more of Quality Assurance experience in medical devices
  • 5-7 years of quality assurance management experience required
  • Proven track record managing teams of individual contributors
• Medical device and regulated industry expertise
  • New Product Introduction (NPI) processes and lifecycle management
  • Verification and validation testing protocols
  • High-reliability product development for medical or aerospace industries
• Regulatory compliance experience
  • FDA QSR, EU MDR, ISO 13485, and/or AS9100 expertise

Knowledge, Skills & Abilities

• Advanced quality methodologies
• Total Quality Management (TQM) and Six Sigma programs
• Design of Experiments (DOEs) and statistical techniques
• Lean Thinking principles
• Leadership and management capabilities
• Ability to establish department goals and coordinate diverse resources
• Strong task prioritization and problem-solving skills to ensure timely completion
• Experience managing multiple projects simultaneously
• Communication and analytical skills
• Excellent verbal and written communication with internal and external stakeholders
• Strong analytical, negotiation, and problem resolution abilities
• Additional requirements
• 15-25% travel required, including international.
• This position serves the 3D Systems Quality Team and involves work with export-controlled products for aerospace and defense customers, requiring compliance with applicable export control regulations.

Preferred Experience

• Multi-site, multi-country operations experience
• Customer-facing experience in quality leadership roles
• CQE, CQA, CQM, ISO 13485:2016 Internal or Lead Auditor Certifications preferred
• Certified Six Sigma Black Belt (CSSBB) - ASQ or equivalent preferred

Applications accepted online through June 9, 2025

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