3D Systems, Inc. Director, Global Quality in Littleton, Colorado
The Global Quality Director leads the Healthcare Solutions business in developing and enhancing 3D Systems’ Quality strategy. Ensures customer satisfaction and corporate goals are achieved or exceeded. This role requires strong collaboration across Advanced Manufacturing, Personalized Health Services, Medical Device Software, and the Application Innovation Group. Partners with Quality site leaders and Manufacturing Engineering to provide clear strategic alignment to ensure both functional, operational, and business needs are met. Defines a quality roadmap that improves customer satisfaction, employee satisfaction, and higher stakeholder value. Constantly acts as a change agent.
The Quality Director has the following responsibilities:
Oversee Quality Teams at 4 locations:
Lead and mentor the efforts of the Quality Team, including providing a clear strategy and vision aligned with business needs. Responsibilities include staffing, performance evaluations, and career development, including setting employee objectives linked to business initiatives and other key performance indicators.
Provides leadership to the Littleton, CO, Leuven, Belgium, Airport City, Israel, and Herndon, Virginia sites in steering all quality management systems activities, including Management Review process, Customer Complaint System, Corrective/Preventive Action System, Training, Supplier Quality, and Internal Audit System.
Provides the direction/coordination/education/tools needed to achieve and maintain registration and compliance with the following standards:FDA QSR, European MDD/MDR, ISO 13485, AS/EN 9100 and other applicable ISO/EN standards.
Support the development, maintenance, performance, and supervise implementation of Design Control procedures for all NPI.
Embraces 3D Systems’ corporate values, behaviors and employee engagement tools to build a high performing and fulfilling team atmosphere.
Lead Quality Initiatives:
Recommends strategy, and is accountable for delivering on proposals, through extensive 1 year and 3 year business planning.
Supports internal and external audit activities, and functions as subject matter expert for product complaints, CAPA root cause investigations and dispositions, and nonconforming materials processes.
Acts as the focal point for ISO, Regulatory and Customer Audits of the Quality Management System.
Partners with Engineering, Manufacturing, and R&D:
Partners with internal stakeholders to ensure quality, compliance, customer satisfaction, patient safety, and continuous improvement.
Maintain strong understanding of design control and project management to ensure compliance.
Supports manufacturing, component, and non-conforming material investigations, as well as participate on other designated engineering projects.
Delivers on shared Quality/Operational goals (i.e. COPQ, scrap reduction, on-time delivery, and process improvements).
Education and Training
Bachelor’s degree, preferably in engineering
10-15 years of Quality Assurance experience in medical devices; 5-7 years of quality assurance management is preferred with experience managing groups of individual contributors
Experience with new product introduction, processes, associated verification and validation testing, and operating within validated ranges to high reliability products for the medical or aerospace industries.
Prior multi-site experience preferred.
Prior experience in customer facing positions preferred.
Candidates with experience working within systems compliant with FDA QSR, European MDD/MDR, ISO 13485, AS/EN 9100 and other applicable ISO/EN standards will be prioritized.
Knowledge, Skills, & Abilities
Excellent analytical, negotiation, and problem resolution skills are a requirement.
High level of competency in TQM, Six Sigma programs, DOEs, CQE/CQM preferred, and well versed in Lean Thinking.
Ability to establish department goals and coordinate a wide variety of resources to meet quality metrics.
Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion.
Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
Experience or exposure to 5S Systems is a benefit.
Statistical technique knowledge is a requirement.
Excellent written and verbal communication skills.
Excellent skills in managing tasks in a variety of projects.
Travel is required, 15-25% of the time.
A successful candidate for this position will be a U.S. Person
Title: Director, Global Quality
Requisition ID: 200000AU