Colorado Energy Jobs

Colorado Jobs

Job Information

3D Systems Global Quality Director - 200000AG in Littleton, Colorado

The Global Quality Director leads the Healthcare Solutions business indeveloping and enhancing 3D Systems' Quality strategy. Ensures customersatisfaction and corporate goals are achieved or exceeded. This role requiresstrong collaboration across Advanced Manufacturing, Personalized HealthServices, Medical Device Software, and the Application Innovation Group.Partners with Quality site leaders and Manufacturing Engineering to provideclear strategic alignment to ensure both functional, operational, andbusiness needs are met. Defines a quality roadmap that improves customersatisfaction, employee satisfaction, and higher stakeholder value.Constantly acts as a change agent.Essential FunctionsThe Quality Director has the following responsibilities:Oversee Quality Teams at 4 locations:Lead and mentor the efforts of the Quality Team, including providing a clearstrategy and vision aligned with business needs. Responsibilities includestaffing, performance evaluations, and career development, includingsetting employee objectives linked to business initiatives and other keyperformance indicators.Provides leadership to the Littleton, CO, Leuven, Belgium, AirportCity, Israel, and Herndon, Virginia sites in steering all qualitymanagement 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 achieveand maintain registration and compliance with the following standards: FDAQSR, European MDD/MDR, ISO 13485, AS/EN 9100 and other applicableISO/EN standaSupport the development, maintenance, performance, and superviseimplementation of Design Control procedures for all NPI.Embraces 3D Systems' corporate values, behaviors and employee engagementtools 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 subjectmatter expert for product complaints, CAPA root cause investigations anddispositions, and nonconforming materials processes.Acts as the focal point for ISO, Regulatory and Customer Audits of theQuality Management System.Partners with Engineering, Manufacturing, and R.and.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 toensure compliance.Supports manufacturing, component, and non-conforming materialinvestigations, as well as participate on other designated engineeringprojectsDelivers on shared Quality/Operational goals (i.e. COPQ, scrapreduction, on-time delivery, and process improvements).Education and TrainingBachelor's degree, preferably in engineering10-15 years of Quality Assurance experience in medical devices; 5-7 years ofquality assurance management is preferred with experience managing groups ofindividual contributorsExperienceExperience with new product introduction, processes, associatedverification and validation testing, and operating within validated rangesto 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/ENstandards will be prioritized.Knowledge, Skills, .and. AbilitiesExcellent analytical, negotiation, and problem resolution skills are arequirement.High level of competency in TQM, Six Sigma programs, DOEs, CQE/CQMpreferred, and well versed in Lean Thinking.Ability to establish department goals and coordinate a wide variety ofresources to meet quality metrics.Ability to evaluate, prioritize and problem solve a variety of tasks toensure the

DirectEmployers