What are the responsibilities and job description for the Quality System Specialist - Design Quality position at Bio-Rad Laboratories, Inc.?
Overview
The Design Quality Engineer 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 device 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 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 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'll Bring
- 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.
- Master’s degree in a health sciences, life sciences, or engineering discipline.
- 3–4 years of direct experience in a quality role supporting Design Controls.
- Highly proficient in ISO 13485, ISO 14971, MDSAP, and IVDR requirements.
- Fluent in English, French is a plus
- Rigorous, detail-oriented, and results-driven.
- Experience supporting multi-site projects.
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. Recently voted a Best Place to Work, 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.
Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our 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. We’re proud to offer a variety of options, including:
- Life and accident insurance,
- Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
- Competitive salary and cafeteria
- 100% commuting allowance for non-Budapest residents, monthly BKK pass
- Annual bonus
- Annual salary review
- Marriage and childbirth allowance
- School start allowance
- Loyalty award
- Employee Referral Program with remarkable referral bonus
- All You Can Move contract possibility/gym facility usage for free of charge
- Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)