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