Quality Engineer 4 - Risk Management

Quality Engineer 4 - Risk Management

San Diego, CA, United States

**The Quality Engineer Level 4 – Risk Management** is a senior, highly experienced individual contributor responsible for leading complex risk management activities across the medical device and/or in-vitro diagnostic product lifecycle. The role provides technical leadership for product, process, software, supplier, manufacturing, service, labeling, and quality system risk management activities. This position supports new product development, sustaining engineering, manufacturing, post-market surveillance, complaints, CAPA, change management, audits, and regulatory inspection readiness.

The role works independently, applies advanced technical judgment, mentors others, and partners cross-functionally with Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market teams to ensure risk management practices are technically justified, docu...