Quality Engineer
Avalign Technologies · Fort Wayne, Indiana, US
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing q...
Job description
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce. The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met. What You’ll Do: - Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485. - Supports operations and engineering teams to ensure the Material Review Board process is followed. - Provides ongoing quality engineering sup...