Senior Design QA Lead for Medical Devices

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

Benefits offered by this job

Competitive medical plans for you and

Free HSA funds

Fertility offering with stipend

401k plus profit sharing

Employee stock purchase program

Learning and development programs

Education benefits

Paid parental leave

Wellness challenges and support

Job summary

Bio-Rad Laboratories in Hercules, CA seeks a Design Quality Assurance (DQA) Manager who will lead design control, risk management, software cybersecurity, and compliance across NPD and lifecycle support for Bio-Rad's IVD and non-IVD products.

You will build and lead a team of design quality engineers, allocate resources, ensure 21 CFR 820, ISO 13485, IVDR and IEC standards, and collaborate with R&D, Regulatory Affairs, Operations and senior leadership to drive safe, effective products.

Qualifications

• Bachelor's degree or equivalent in a scientific or engineering discipline.
• 8+ years' relevant quality systems experience with supervisory experience.
• Experience in a medical device, pharmaceutical or other regulated industry.
• Global/interfacing with multiple locations is a plus.
• Quality Engineer, Quality Manager, Six Sigma or related credentials desirable.

Responsibilities

• Lead design control and design assurance across NPD and lifecycle.
• Manage risk management per ISO 14971:2019 with related guidance.
• Oversee software lifecycle and cybersecurity integration.
• Ensure regulatory compliance (FDA, IVDR, ISO 13485, EMC/IEC).
• Recruit, coach, and manage a team of design quality engineers.

Skills

Leadership

Quality management

Regulatory affairs

Risk management

Communication

Education

Bachelor's degree or equivalent

Job description

Bio-Rad Laboratories in Hercules, CA seeks a Design Quality Assurance (DQA) Manager who will lead design control, risk management, software cybersecurity, and compliance across NPD and lifecycle support for Bio-Rad's IVD and non-IVD products.

You will build and lead a team of design quality engineers, allocate resources, ensure 21 CFR 820, ISO 13485, IVDR and IEC standards, and collaborate with R&D, Regulatory Affairs, Operations and senior leadership to drive safe, effective products.