Senior Design Quality Assurance Leader

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

Benefits offered by this job

Medical plans

HSA funds

Fertility stipend

401k + profit sharing

Employee stock purchase program

Mental health platform

Job summary

Bio-Rad Laboratories seeks a Design Quality Assurance (DQA) Manager in Hercules, CA. You will lead design control, risk management, software and cybersecurity provisions for NPD and lifecycle management of Bio-Rad's IVD and non-IVD products, aligning with FDA 21 CFR 820, ISO 13485, IVDR, and other global standards.

As a working manager, you’ll mentor a team of design quality engineers, coordinate with R&D, Regulatory Affairs, Operations, and QA to ensure compliant, robust DHF, CAPA, and product

Qualifications

• Bachelor's degree in scientific or engineering field required or equivalent experience.
• 8+ years in quality systems in regulated environments (medical device/pharma) preferred.
• Experience leading design control, risk management and cross-functional collaboration.
• Familiarity with FDA QMS regulations (21 CFR 820), ISO 13485, IVDR is highly desirable.

Responsibilities

• Lead design control and design assurance activities across NPD and LCM.
• Manage risk management per ISO 14971 and related guidance.
• Oversee software, cybersecurity, and electrical safety considerations in medical devices.
• Coordinate with R&D, Regulatory Affairs, Operations and QA on design documentation and audits.
• Act as SME for inspections and certifications (FDA, MDSAP, IVDR).
• Develop and mentor a team of design quality engineers.

Skills

Leadership

Risk management

Communication

Decision-making

Education

Bachelor's degree in scientific/engineering discipline

Job description

Bio-Rad Laboratories seeks a Design Quality Assurance (DQA) Manager in Hercules, CA. You will lead design control, risk management, software and cybersecurity provisions for NPD and lifecycle management of Bio-Rad's IVD and non-IVD products, aligning with FDA 21 CFR 820, ISO 13485, IVDR, and other global standards.

As a working manager, you’ll mentor a team of design quality engineers, coordinate with R&D, Regulatory Affairs, Operations, and QA to ensure compliant, robust DHF, CAPA, and product