Quality Engineer I

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.

How You’ll Make An Impact: 

• 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.

What You Bring: 

• 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.

Location: This position must be based in Pleasanton, 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's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability,  paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more! 

Compensation: The estimated base salary range for this position is $70,310 to $95,400 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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