Bio-Rad is seeking an experienced Senior Quality Engineer to lead timely implementation of IVDR Risk Management and Post Market Surveillance requirements for its regulated products and processes. This role will support multiple sites in the US, which will require remote meetings and future occasional travel with teams located outside of the Hercules/Benicia CA location including Seattle WA, Irvine CA and Fort Worth TX.

• Establishing a strategy and step by step approach for Risk Management and related Technical File documentation to ensure compliance with EU IVDR, ISO 14971:2019 and 62366:2015 requirements. Also leading and overseeing a risk-based work plan to accomplish the strategy within a fixed project schedule.
• Partnering with Regulatory Affairs, Clinical Affairs, R&D, Marketing and Manufacturing to produce new documentation evaluating initial and on-going product performance through the lifecycle of the product.
• Compiling and analyzing information to identify unacceptable trends and benefit-risk conclusions with the goal of driving suitable corrective actions needed to maintain safe and effective products.
• Contributing to and/or reviewing health hazard analyses and product risk assessments for issues potentially impacting patient outcomes.
• Assessing technical product and QMS documentation such as test protocols, reports, manufacturing procedures, complaints, nonconformances, CAPA, change orders, etc.
• Mentoring peers and lower level Quality Engineers in the application of Risk Management requirements and industry best practices.
• Supporting regulatory submission questions and on-site audits. • Assisting RAQA leadership with communication of status and needs to executive management team members.