Senior Design Quality Assurance Manager

Bio-Rad Laboratories, Inc; Hercules (CA); On-site; USD 138,000 - 189,000; Full time

Benefits offered by this job

Competitive medical plans

Free HSA funds

Retirement benefits (401k)

Employee stock purchase program

Learning & development opportunities

Job summary

Bio-Rad Laboratories, Inc seeks a Design Quality Assurance Manager to lead design control and design assurance for Bio-Rad’s IVD and non-IVD products. The role combines hands-on QA, risk management, software and cybersecurity oversight, and team leadership across R&D, Regulatory Affairs, Operations, and senior leadership.

You will allocate resources, drive phase-gate decisions, ensure compliance with FDA 21 CFR 820, ISO 13485, IVDR, and relevant EMC/cybersecurity standards, and prepare teams for

Qualifications

• Education: Bachelor's degree in a scientific or engineering discipline.
• 8+ years' quality systems experience with supervisory responsibilities.
• Experience in regulated industries (medical device/pharma) with FDA 21 CFR 820, MDSAP, IVDR, ISO 13485, ISO 14971.
• Global/multi-site experience is a plus.
• Strong communication, public speaking, and decision-making under pressure.

Responsibilities

• Lead design quality assurance activities across NPD and LCM.
• Allocate and manage design QA resources across projects.
• Provide design control deliverable sign-off and escalation.
• Interface with RAQA, R&D, Operations, and senior leadership.
• Coordinate with audits/inspections (FDA, MDSAP, IVDR).
• Oversee risk management per ISO 14971 and software lifecycle standards.

Skills

Quality systems leadership

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's degree in science/engineering

Job description

Bio-Rad Laboratories, Inc seeks a Design Quality Assurance Manager to lead design control and design assurance for Bio-Rad’s IVD and non-IVD products. The role combines hands-on QA, risk management, software and cybersecurity oversight, and team leadership across R&D, Regulatory Affairs, Operations, and senior leadership.

You will allocate resources, drive phase-gate decisions, ensure compliance with FDA 21 CFR 820, ISO 13485, IVDR, and relevant EMC/cybersecurity standards, and prepare teams for