Quality Engineer 3 - Risk Management

San Diego, CA, United States

The **Quality Engineer Level 3 – Risk Management** is an experienced individual contributor within Regulatory and Quality for Diagnostics. This role is 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. The position supports new product development, sustaining activities, manufacturing, supplier quality, post-market surveillance, complaints, CAPA, nonconformances, and change management.

The role partners with cross-functional teams, including Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market 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 e...