Quality Systems Manager

Quality Systems Manager

As Quality Systems Manager for 3D Systems Advanced Manufacturing organization, you will serve as the architect of operational excellence, ensuring our organization consistently delivers products and services that meet customer specifications, industry standards (e.g., ISO 9001, ISO 13485, AS 9100), and regulatory requirements across our global advanced manufacturing organization. You and your team will design, implement, and maintain the frameworks that prevent defects and drive continuous improvement. We seek an individual who thrives on optimizing processes and fostering a culture of quality across the business.

What's In It For You!

• Competitive Pay: 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, flexible working schedules 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 13 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:

• System Development & Oversight Design, implement, and continuously improve QMS framework in alignment with strategic business goals and regulatory requirements. Ensure completeness and conformity with standards including but not limited to ISO 9001, AS9100, ISO 13485, FDA 21 CFR 820 (QMSR), MDSAP (Health Canada, TGA, US), ANVISA, EU MDR, and UKCA requirements Manage document control systems and ensure quality policies, standard operating procedures (SOPs), and quality manuals are up to date. Lead the Change Control process to ensure controlled, compliant, and timely modifications. Develop and execute plans to address regulatory changes to ensure timely completion and continued certification.
• Audit & Compliance Management Provide expertise in interpreting and applying regulatory and governmental requirements, ensuring ongoing compliance. Schedule and conduct internal audits to assess the effectiveness and compliance of all company processes. Facilitate external audits from certification bodies, regulatory agencies, and clients. Track and resolve non-conformances, ensuring appropriate corrective and preventive actions (CAPAs) are executed and verified to ensure continued compliance.
• Continuous Improvement & Leadership Create performance dashboards and report on key quality metrics (KPIs) to senior management. Chair Corrective Action and Preventative Action (CAPA) Review Board, ensuring rigorous root cause analysis and timely implementation of effective corrective and preventative actions. Recruit, develop, and mentor quality personnel to ensure effective team performance. Mentor and train employees on quality management principles, protocols, and best practices. Collaborate with process owners to establish and maintain training programs in compliance with QMS and certification requirements.

Qualifications What You Will Bring: Bachelor's degree in engineering, business administration, quality management, or a related technical/life sciences field. 5+ years in quality systems management or quality assurance, ideally within a heavily regulated manufacturing or production environment. Proven track record of team leadership. Experience in regulated industries such as medical devices 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. Excellent verbal and written communication with internal and external stakeholders Strong analytical, negotiation, and problem resolution skills. Deep understanding of frameworks like ISO 9001, AS9100, ISO 13485, or FDA/GMP standards. Familiarity with electronic Quality Management Systems (eQMS) software, document control platforms, and statistical data analysis tools. 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