Global Quality Engineering Lead

We are seeking a highly skilled and strategic Global Quality Engineering Leader to establish and lead a new global Quality Engineering (QE) function within our Product Quality organization. In this pivotal role you will drive standardization, technical excellence, and continuous improvement across our global network of manufacturing sites and commercial distribution operations supporting regulated medical device and clinical diagnostics products. Also you will shape and execute the global QE strategy, building a cohesive organization that ensures robust processes, scalable validation practices, risk-based decision-making, and flawless design transfer into manufacturing. This is an opportunity to have a lasting impact on product quality, compliance, and operations performance at a global scale.

How You’ll Make An Impact: 

Strategic Leadership & Organization Building:

• Build and lead a new global Quality Engineering function, including hiring, developing, and mentoring a high-performing team of 3-5 direct reports and an extended network of QE professionals across sites.
• Develop the vision, strategy, and roadmap for global quality engineering to support current and future business growth
• Serve as the primary quality engineering leader and subject matter expert across manufacturing, new product introduction, and commercial distribution operations.

Process Standardization & Technical Excellence:

• Establish and deploy standardized global procedures for:
  • Process Validation (IQ/OQ/PQ)
  • Statistical Process Control (SPC) and trending
  • Process FMEAs and control plans
  • Design Transfer into manufacturing
• Partner with site quality and operations leaders to ensure consistent implementation, governance, and sustained compliance with global standards and regulatory expectations
• Collaborate with GSC, R&D, Design QA, Manufacturing, and RA to align design outputs with process capabilities and quality requirements
• Ensure smooth technology transfer and scale-up from development to commercial production.

Data Driven Quality & Continuous Improvement

• Champion a data-driven approach to quality engineering, leveraging SPC, capability analysis, and advanced quality tools to proactively identify and mitigate risks
• Drive continuous improvement projects that enhance product performance, reduce variability, improve yield, and lower Cost of Poor Quality (CoPQ)
• Establish KPIs and dashboards to measure and communicate the impact of QE initiatives globally. 

Cross-Functional Collaboration & Leadership

• Partner closely with site quality leaders, operations, R&D, regulatory, and supply chain teams to embed quality engineering principles into daily operations and decision-making
• Serve as key voice in global governance forums, technical reviews, and quality councils
• Represent Bio-Rad during audits and regulatory inspections related to process validation, risk management, and quality engineering practices

What You Bring:

• Education: Bachelor’s degree in Engineering, Life Sciences, or related technical field required; advanced degree preferred. 
• Work Experience: 6+ years’ experience in quality engineering, process validation, or manufacturing quality roles within the medical device, IVD, or regulated life sciences industry. 
• Deep expertise in process validation (IQ/OQ/PQ), SPC, TMV, risk management (ISO 14971), pFMEA, and design transfer. 
• Strong understanding of FDA QSR/QMSR, ISO 13485, and other applicable global regulatory requirements. 
• Experience with statistical analysis tools, quality systems software, and continuous improvement methodologies (Lean, Six Sigma, etc.). 
• Demonstrated ability to build, lead, and develop high-performing teams in a global, matrixed organization. 
• Excellent communication and influencing skills, capable of driving alignment across functions and geographies. 
• Strategic thinker with hands-on execution ability and a passion for building from the ground up.

Location: Bio-Rad is pleased to offer the flexibility of Remote Work for this role anywhere in the U.S.

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 annual salary for this position is $107,000 to $184,200 at the time of posting. This range is inclusive of all geographic locations within the United States*.  Actual compensation will be provided in writing at the time of an offer, if applicable, and is based on several factors we believe fairly and accurately impact compenstion, 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. 

*Minimum reflects our lowest paying locations, and the top end reflects our highest paying locations. The range in your geographic location will vary but will be within the indicated ranges. 

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.

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-AK1 #LI-Remote