Quality Systems Manager

3D Systems•Littleton, CO

1d•Hybrid

About The Position

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.

Requirements

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
15-25% travel required, including international.
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.

Nice To Haves

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

Responsibilities

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.
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.
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.