Quality Engineer I — On-Site Life Sciences QA

Bio-Rad Laboratories; Hercules (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Bio-Rad Laboratories in Hercules, CA is seeking a Quality Engineer I to apply quality engineering principles across the product lifecycle, ensuring designs meet internal procedures and regulatory requirements. You will use risk management and problem solving to prevent failures and improve product quality, supporting life science and clinical diagnostic manufacturing.

You will actively participate in investigations, root cause analyses, corrective actions, and on-the-floor process improvements,

Qualifications

• Bachelor's degree (BA/BS) or equivalent.
• GMP/ISO regulations and validation knowledge preferred.
• Strong problem solving and analytical skills.
• Ability to work in fast-paced, cross-functional teams.
• Excellent written and verbal communication.

Responsibilities

• Provide engineering support to manufacturing and resolve nonconforming product issues using a risk-based approach.
• Identify process improvements on the manufacturing floor and lead investigations and corrective actions.
• Ensure compliance with safety, quality, and regulatory requirements (FDA/ISO) via product and quality system changes.
• Participate in Quality Review Boards and perform data analysis to identify trends.
• Execute New Product Introduction and Design Transfer activities including FMEA, IQ/OQ/PQ.
• Lead validation activities for equipment and processes.

Skills

Quality engineering

Cross-functional teamwork

Problem solving

Communication skills

GMP/ISO regulations

Education

Bachelor's degree

Job description

Bio-Rad Laboratories in Hercules, CA is seeking a Quality Engineer I to apply quality engineering principles across the product lifecycle, ensuring designs meet internal procedures and regulatory requirements. You will use risk management and problem solving to prevent failures and improve product quality, supporting life science and clinical diagnostic manufacturing.

You will actively participate in investigations, root cause analyses, corrective actions, and on-the-floor process improvements,