Lead Design Quality Assurance for Regulated Med Devices

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

Job summary

Bio-Rad Laboratories in Hercules, CA seeks a Design Quality Assurance Manager to lead design control and design assurance across the portfolio, including NPD and lifecycle management for IVD and related products. You will allocate resources, escalate critical issues, and ensure compliance with FDA, ISO and EU standards.

You will manage a team of design quality engineers, collaborate with R&D, RAQA, Operations, and leadership to drive risk management, cybersecurity, and product safety, while

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 8+ years of relevant quality systems experience with supervisory responsibilities.
• Experience with FDA 21 CFR 820, MDSAP, IVDR, ISO 13485 and related global standards.
• Experience supporting FDA inspections, MDSAP audits, and/or notified body assessments is a plus.

Responsibilities

• Lead design quality assurance across NPD and LCM projects.
• Ensure compliance with FDA QMSR, ISO 13485, ISO 9001 and EU IVDR requirements.
• Provide design assurance sign-off at phase gates with documented rationale.
• Coordinate with R&D, Regulatory Affairs, Operations and senior leadership.

Skills

Leadership

Communication

Decision-making

Public speaking

Education

Bachelor's degree in a scientific or engineering discipline

Job description

Bio-Rad Laboratories in Hercules, CA seeks a Design Quality Assurance Manager to lead design control and design assurance across the portfolio, including NPD and lifecycle management for IVD and related products. You will allocate resources, escalate critical issues, and ensure compliance with FDA, ISO and EU standards.

You will manage a team of design quality engineers, collaborate with R&D, RAQA, Operations, and leadership to drive risk management, cybersecurity, and product safety, while