Quality Engineer

Overview

The Design Quality Engineer I supports Bio-Rad’s commitment to quality by ensuring that product deliverables comply with applicable regulatory and quality standards. Bio-Rad Laboratories designs and manufactures highly complex medical devices and in vitro diagnostic (IVD) products, and this role requires a strong quality-focused leader to support projects related to the development of next-generation technologies. As a core member of the cross-functional product development team, the Design Quality Engineer I supports products from concept through commercialization.

This position provides quality expertise and guidance in design controls, risk management, process validation, and design for manufacturability and reliability. The role also ensures that product development activities meet internal quality system requirements as well as all applicable external regulatory and design control standards.

• Partner cross-functionally to provide Design Quality support for New Product Development (primary focus) and design changes across the product lifecycle.
• Ensure Design Quality activities comply with applicable regulatory and quality standards, including ISO 13485, IVDR, FDA, and ISO 14971.
• Provide Design Quality guidance to global teams to ensure consistent application of quality processes across European sites and other regions (Americas, Asia), supporting effective development and maintenance of Design History Files (DHFs).
• Ensure design deliverables, including DHFs and Risk Management documentation, meet internal quality system and external regulatory requirements.
• Drive continuous improvement of global Design Quality processes, identifying and proposing opportunities.
• Participate in design reviews, design sessions, and internal and external audits, providing Design Quality input and oversight through product launches and ensuring readiness for commercialization.
• Collaborate with Post-Market Surveillance (PMS) partners to ensure relevant design changes are appropriately reflected in Product Surveillance Reports.
• Partner with Risk Management to ensure design FMEAs (dFMEA) are updated when product risk profiles change.
• Promote and reinforce a strong culture of quality across product development and the broader organization.

• Education:
  
  Bachelor s degree in a health sciences, life sciences, or engineering discipline. Masters preferred
• Work Experience:
  
  1–3 years of direct experience in a quality role supporting Design Controls.
• Highly proficient in ISO 13485, ISO 14971, MDSAP, and IVDR requirements.
• Rigorous, detail-oriented, and results-driven.
• Experience supporting multi-site projects.
• French speaking is a plus but not required.
• Demonstrates initiative in driving process improvements aligned with Bio-Rad values, with a strong focus on product quality.
• Exhibits assertiveness and confidence to guide project leads and stakeholders in a pragmatic manner to ensure effective DHF maintenance and compliance throughout the product lifecycle.
• Strengthens global collaboration by serving as a point of contact between regions.
• Applies strong technical knowledge and keen attention to detail to ensure Bio-Rad consistently meets deliverables in a timely and compliant manner.
• Demonstrates a high level of emotional intelligence, patience, and a supportive approach when working with teams managing shifting priorities.

This position must be based in Hercules, CA and requires the employee to be located within commuting distance of the office.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad offers benefits to enrich the overall health, wealth, and wellbeing of employees and their families.

Benefits: Medical plans, HSA funds, fertility offering with stipend, group life and disability, parental leave, 401k with profit sharing, employee stock purchase program, mental health platform, learning and development opportunities,…