Quality Engineer I

About the role

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.

Responsibilities

• 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.
• Promote and reinforce a strong culture of quality across product development and the broader organization.

Requirements

• 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.

Qualifications

• 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.

Skills

• Strong technical knowledge in quality systems and regulatory requirements.
• Excellent communication and collaboration skills.
• Ability to manage multiple projects and prioritize tasks effectively.
• Proficiency in Microsoft Office Suite.

Benefits

• Competitive medical plans for you and your family.
• Free HSA funds.
• New fertility offering with stipend.
• Group life and disability.
• Paid parental leave.
• 401k plus profit sharing.
• Employee stock purchase program.
• 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).

Pay

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.

Schedule

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