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.
8+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
Advanced knowledge of and application of Quality Engineering and Risk Management required.
Regulatory experience or RAC is desired.
Detail-oriented, excellent organization and project management skills are needed to meet expectations.
Decision making, time management, communication, leadership, and computer skills.
SalesForce, SAP and Power BI experience is a plus.
Additional Salary Information: Our Benefits Program provides affordable choices from a comprehensive set of plans, covers the full range of life-stage needs, provides security from catastrophic loss, encourages wellness, cultivates a partnership between you and Bio-Rad, allows Bio-Rad to remain competitive in the marketplace
Internal Number: 2020-13201
About Bio-Rad Laboratories
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.