Design Quality Assurance Lead – Regulated Medical Devices

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

Job summary

Bio-Rad Laboratories, Inc. is seeking a Design Quality Assurance (DQA) Manager to lead design control and design assurance activities across Bio-Rad’s IVD portfolio and non-IVD laboratory products.

The role involves allocating resources, serving as decision-maker for project issues, and guiding compliance with FDA, MDSAP, ISO 13485, and IVDR requirements. You will lead a team of design quality engineers, drive risk management, software/cybersecurity, and ensure readiness for audits and

Qualifications

• 8+ years’ relevant quality systems experience with supervisory experience.
• Experience in regulated industries (medical device/pharma) with knowledge of FDA 21 CFR 820, IVDR/ISO 13485.
• Strong leadership and cross-functional collaboration with R&D, RAQA, and operations.

Responsibilities

• Allocate and balance design quality assurance resources across NPD and LCM projects; maintain a forward-looking resource model aligned to program stage-gate schedules and business priorities.
• Own design assurance deliverables and approvals across the full product life cycle: design and development planning, design inputs, design outputs, design reviews, verification, validation, design transfer, design changes, and DHF completeness and inspection readiness.
• Lead the assessment and applicability determination of standards, regulations, and requirements for the assigned portfolio covering IVD and non-IVD laboratory products; maintain matrices and remediation plans.
• Recruit, coach, develop, and manage the performance of a team of design quality engineers; build depth across design control, risk management, and standards compliance.

Skills

Leadership

Resource planning

Communication

Regulatory knowledge

Risk management

Education

Bachelor’s degree or equivalent in scientific or engineering discipline

Job description

Bio-Rad Laboratories, Inc. is seeking a Design Quality Assurance (DQA) Manager to lead design control and design assurance activities across Bio-Rad’s IVD portfolio and non-IVD laboratory products.

The role involves allocating resources, serving as decision-maker for project issues, and guiding compliance with FDA, MDSAP, ISO 13485, and IVDR requirements. You will lead a team of design quality engineers, drive risk management, software/cybersecurity, and ensure readiness for audits and