Quality Engineer Level 3 – Risk Management

The Quality Engineer Level 3 – Risk Management is an experienced individual contributor within Regulatory and Quality for Diagnostics, responsible for performing and maintaining product and process risk management activities for medical device and/or in-vitro diagnostic products across the full product lifecycle. This role supports new product development, sustaining activities, manufacturing, supplier quality, post-market surveillance, complaints, CAPA, nonconformances, and change management. The position partners with cross-functional teams to ensure risk management activities are completed in accordance with applicable quality system requirements, FDA regulations, ISO 13485, ISO 14971, and other relevant medical device and IVD regulatory expectations.