LightForce Orthodontics is looking to solve the problem of ensuring efficient, high-quality production of their orthodontic products while driving continuous improvement initiatives and maintaining regulatory compliance. This involves owning the sustainment and improvement of current manufacturing processes, overseeing quality management systems, leading a quality team, and successfully transitioning new products into full-scale production.
Requirements
- Deep understanding of manufacturing processes, equipment, and production technologies including 3D printing, with proficiency in process validation and equipment qualification
- Experience implementing lean manufacturing methodologies with a data-driven approach to continuous improvement and complex problem-solving
- Demonstrated expertise in technical supplier management, including qualification, performance assessment, and driving compliance with quality standards
- Knowledge of regulatory requirements for medical device manufacturing (FDA, ISO 13485, etc.)
- Experience with automated inspection and computer vision systems
- Experience managing complex technical supplier relationships in regulated industries
- Experience establishing and maintaining supplier quality agreements
Responsibilities
- Lead and develop teams of manufacturing engineers and quality professionals responsible for production floor operations, quality assurance, process improvement, and new product introductions
- Build and manage a dedicated quality team responsible for maintaining the Quality Management System (QMS) and ensuring regulatory compliance
- Own the manufacturing process from initial process development through validation to sustained production with focus on quality excellence
- Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with FDA, ISO 13485, and other relevant regulatory requirements
- Oversee internal and external quality audits, including preparation, execution, and corrective action implementation
- Drive continuous improvement initiatives to enhance production efficiency, quality, throughput, and cost reduction
- Ensure regulatory compliance throughout the manufacturing process and lead regulatory submissions related to manufacturing changes
Other
- Lead and develop teams of manufacturing engineers and quality professionals
- Strong leadership skills with ability to build and develop high-performing manufacturing engineering teams in regulated environments
- Strong project management capabilities with ability to effectively manage multiple priorities in a fast-paced manufacturing environment
- Excellent cross-functional collaboration and communication skills with ability to work effectively across R&D, Quality, Operations, and external partners
- Regular presence on the manufacturing floor requiring prolonged standing, walking, and movement
