Arthrex - Corkscrew, FL
posted 2 months ago
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for a Senior Engineer - Quality Assurance (QA) for our manufacturing site in Ave Maria, FL. The Senior Engineer - QA will be responsible for various Quality Assurance functions related to the manufacturing development of medical devices. This role is crucial in ensuring that our products meet the highest standards of quality and compliance throughout the manufacturing process. The ideal candidate will possess a Bachelor's degree in Engineering and have over 5 years of experience with continuous improvement manufacturing processes in a highly regulated industry. This position requires strong leadership skills, as well as the willingness and ability to mentor Quality Assurance team members. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. In this role, you will participate in the development of medical devices and components from design initiation through design transfer, representing Quality Assurance for manufacturability in all design and development project teams. You will also be involved in all manufacturing activities to ensure compliance with design specifications. Leading the development of quality plans for new product introductions based on design specifications, PFMEA, and control plans will be a key responsibility. You will work closely with the design team to provide feedback on design specifications and improvements, evaluate and develop effective testing and inspection methods, and utilize problem-solving tools and techniques to address issues. Additionally, you will determine the necessity of testing, initiate testing by preparing test and inspection plans, and ensure that all information and documentation is consistently accurate. You will be responsible for MRB activities for assigned products, resolving nonconformities, and issuing or monitoring corrective actions associated with deviations. Providing technical support on manufacturing issues and supervising other engineers, technicians, and support personnel may also be part of your duties. This position is integral to maintaining the quality and integrity of our manufacturing processes and products.