Responsible for leading quality engineering team for design, development transfer, QA manufacturing and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals.
Essential Duties and Responsibilities:
Manages Quality Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design and operation support activities to provide timely and efficient flow of services and projects.
Maintains a leading edge understanding of the quality processes required in designing, manufacturing and post market performance of arthroscopic, orthopedic devices and capital equipment in order to find new and novel opportunities to improve product quality and reduce cost.
Effectively implements enhancements and improvements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirement, e.g., ISO 13485, 21 CFR 820, European MDR, etc...
Ensures effective implementation of reference standards in the execution of quality-related actives, e.g., ISO 14971, IEC 62366, etc.
Fosters consistent quality input and partners with design & manufacturing engineering and operations to support new product development and sustaining engineering activities
Provides Quality Engineering project oversight and management, including initiating and leading cross-functional teams.
Generates and oversees the development quality timelines for new product introduction and sustaining quality engineering activities.
Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of product design-related corrective and preventive actions (CAPA);
Leads hiring and developing the quality engineering team by actively coaching and providing career development assistance to team members;
Develops future leaders by effective selection, mentorship, and development activities;
Reports progress and status of projects on a timely basis with emphasis on reporting results to upper management.
Uses appropriate statistical tools/methodologies to drive quality improvements in product lines.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor of Science Degree in Engineering required.
10 years Medical Device Industry experience preferred with a minimum of 3 years supervisory or management experience.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Working knowledge of ISO and FDA quality requirements.
Manufacturing process knowledge.
Technical knowledge in development methodologies, design quality analysis, and project implementation of Medical Devices and supporting accessories.
Proficiency in assessing manufacturing quality requirements of new product ideas