Quality Engineer I

About the Role

A typical day involves reviewing and prioritizing newly logged Bio-Rad product complaints to ensure urgent technical issues are addressed immediately. You will analyze product performance trends, collaborate with manufacturing, R&D, and Product Management teams to investigate root causes, and document findings in the quality management system to maintain strict regulatory compliance. The role includes cross-functional syncs, troubleshooting, and finalizing investigation reports to contribute to swift resolutions that support and satisfy customers.

How You’ll Make an Impact

• 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.

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; 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, 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.

Location

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

Benefits

• Competitive medical plans for you and your family, including free HSA funds.
• New fertility offering with stipend.
• Group life and disability insurance.
• Paid parental leave.
• 401k plus profit sharing.
• Employee stock purchase program.
• Upgraded and streamlined mental health platform.
• Extensive learning and development opportunities, education benefits, and student debt relief program.
• Pet insurance.
• Wellness challenges and support.
• Paid time off.
• Employee Resource Groups (ERGs).

Pay

The estimated base salary range for this position is $70,400 to $95,400 at the time of posting. Actual compensation will be based on geographic location, experience, knowledge, skills, abilities, and other job-related factors. This position is also eligible for a variable annual bonus, dependent upon achievement of individual objectives and Company performance.