Quality Manager

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. Avalign is currently seeking a Quality Manager at our facility located in Schaumburg, IL. What You Will Do: - Lead and direct regulatory (e.g. FDA and ISO), internal and external (customer) audits within the company to ensure compliance to applicable regulatory and corporate standards / requirements are met. This includes developing and maintaining an audit schedule, performing internal audits, scheduling personnel to assist with audits, maintaining a list of qualified internal auditors, writing and issuing audit reports, and verifying corrective actions - Manage a successful CAPA system, including initiation, support of the root cause investigation, closure, and verif...