Quality Engineer I

Bio-Rad Laboratories•Hercules, CA

1d•Onsite

About The Position

The candidate's day will start by reviewing and prioritizing newly logged Bio-Rad product complaints to ensure urgent technical issues are addressed immediately. They will spend time diving into data, analyzing product performance trends, and collaborating with manufacturing, R&D, and/or Product Manager teams to investigate root causes. Throughout the day, they will meticulously document their findings in the quality management system to maintain strict regulatory compliance. Between cross-functional syncs and troubleshooting, they will finalize investigation reports, directly contributing to swift resolutions that keep customers supported and satisfied.

Requirements

B.S./B.A. (or equivalent) in a scientific or engineering discipline and 2+ years of experience (or an equivalent combination of education and experience).
Basic knowledge of quality engineering principles, theories, and applications.
Basic knowledge of risk management regulations, principles, and applications.
Basic knowledge of statistical methods, process control, and sampling plans.
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820 and FDA CFR Part 210/211).
Strong critical thinking, leadership, and communication skills, with a collaborative attitude and an eagerness to make an impact in a dynamic environment.

Responsibilities

Investigate, analyze, and resolve technical customer complaints regarding Bio-Rad products, ensuring timely and accurate root-cause analysis to maintain high product quality.
Trend and monitor complaint data to identify systemic quality issues, collaborating cross-functionally with R&D and Manufacturing to implement effective corrective and preventive actions.
Ensure all complaint files are documented accurately and closed in strict compliance with FDA, ISO, and other relevant medical device standards.
Act as a vital bridge between customer feedback and internal quality teams, directly impacting client satisfaction and loyalty by resolving issues efficiently.
Contribute to the optimization of the complaint-handling workflow, onboarding documentation, and risk assessment protocols to enhance overall team efficiency.