3D Systems Corporation
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:
$160,000 - $190,000 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):
Company paid holidays and a flexible working schedule through our paid time off (PTO) policy. 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:
Medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Global Team:
Our corporate headquarters are in Rock Hill, South Carolina, with a presence across more than 15 countries worldwide. Innovative Culture:
Innovation is at the heart of what we do. Since 1986, 3D Systems has pushed the boundaries of additive manufacturing. You will have the opportunity to work with cutting-edge technology in an innovative and collaborative culture. Talent Development:
We invest in talent programs to support employees with opportunities to grow and thrive in their careers. Connection & Engagement Opportunities:
Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program empower you to build connections and make a meaningful impact. What You Will Do
Oversee Quality Teams in the 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 KPIs. 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. Maintain ISO 13485, ISO 9001, MDSAP, Medical Device Regulation (MDR), AS/EN 9100 certifications. 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. Qualifications
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. Export control compliance for aerospace and defense customers; work with export-controlled products.
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 September 11th, 2025 #LI-MP1 EEO statement: 3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin; protected veterans. The Company also provides equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including lactation. Primary Location: US-CO-Littleton Work Locations: USA-CO-Littleton 80127 Job Level: Manager with Direct Reports Travel: Yes, 25 % of the Time Type of Position: Employee Job Posting: Sep 4, 2025, 7:56:20 PM
#J-18808-Ljbffr
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:
$160,000 - $190,000 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):
Company paid holidays and a flexible working schedule through our paid time off (PTO) policy. 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:
Medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Global Team:
Our corporate headquarters are in Rock Hill, South Carolina, with a presence across more than 15 countries worldwide. Innovative Culture:
Innovation is at the heart of what we do. Since 1986, 3D Systems has pushed the boundaries of additive manufacturing. You will have the opportunity to work with cutting-edge technology in an innovative and collaborative culture. Talent Development:
We invest in talent programs to support employees with opportunities to grow and thrive in their careers. Connection & Engagement Opportunities:
Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program empower you to build connections and make a meaningful impact. What You Will Do
Oversee Quality Teams in the 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 KPIs. 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. Maintain ISO 13485, ISO 9001, MDSAP, Medical Device Regulation (MDR), AS/EN 9100 certifications. 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. Qualifications
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. Export control compliance for aerospace and defense customers; work with export-controlled products.
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 September 11th, 2025 #LI-MP1 EEO statement: 3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin; protected veterans. The Company also provides equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including lactation. Primary Location: US-CO-Littleton Work Locations: USA-CO-Littleton 80127 Job Level: Manager with Direct Reports Travel: Yes, 25 % of the Time Type of Position: Employee Job Posting: Sep 4, 2025, 7:56:20 PM
#J-18808-Ljbffr