Quality Engineer

Candidate's day will start by reviewing and prioritizing newly logged Bio-Rad product complaints to ensure urgent technical issues are addressed immediately. He/she will spend time diving into data, analyzing product performance trends, and collaborating with manufacturing, R&D, and Product Manager teams to investigate root causes. Throughout the day, he/she will meticulously document their findings in the quality management system to maintain strict regulatory compliance.

Between cross-functional syncs and troubleshooting, he/she will finalize investigation reports, directly contributing to swift resolutions that keep our customers supported and satisfied.

• Resolve Critical Issues:
  Investigate, analyze, and resolve technical customer complaints regarding Bio-Rad products, ensuring timely and accurate root‑cause analysis to maintain high product quality.
• Drive Continuous Improvement:
  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 Regulatory Compliance:
  Champion regulatory excellence by ensuring all complaint files are documented accurately and closed in strict compliance with FDA, ISO, and other relevant medical device standards.
• Safeguard Customer Trust:
  Act as a vital bridge between customer feedback and internal quality teams, directly impacting client satisfaction and loyalty by resolving issues efficiently.
• Elevate Team Processes:
  Contribute to the optimization of the complaint‑handling workflow, onboarding documentation, and risk assessment protocols to enhance overall team efficiency.

• Education/
  
  Work Experience:
  
  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; risk management regulations, principles, and applications; and 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.

This position must be based in Hercules, CA and requires the employee to be located within commuting distance of the office.

At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio‑Rad’s robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401(k) plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

The estimated base salary range for this position is $70,400 to $95,400 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job‑permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and company performance.

For 70 years, Bio‑Rad has focused on advancing the discovery process and transforming the fields of science and…