Quality Engineer I

Bio-Rad Laboratories; Hercules (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Bio-Rad Laboratories in Hercules, CA is seeking a Quality Engineer I to apply quality engineering principles across the product lifecycle, ensuring designs meet internal procedures and regulatory requirements. You will use risk management and problem solving to prevent failures and improve product quality, supporting life science and clinical diagnostic manufacturing.

You will actively participate in investigations, root cause analyses, corrective actions, and on-the-floor process improvements,

Qualifications

• Bachelor's degree (BA/BS) or equivalent.
• GMP/ISO regulations and validation knowledge preferred.
• Strong problem solving and analytical skills.
• Ability to work in fast-paced, cross-functional teams.
• Excellent written and verbal communication.

Responsibilities

• Provide engineering support to manufacturing and resolve nonconforming product issues using a risk-based approach.
• Identify process improvements on the manufacturing floor and lead investigations and corrective actions.
• Ensure compliance with safety, quality, and regulatory requirements (FDA/ISO) via product and quality system changes.
• Participate in Quality Review Boards and perform data analysis to identify trends.
• Execute New Product Introduction and Design Transfer activities including FMEA, IQ/OQ/PQ.
• Lead validation activities for equipment and processes.

Skills

Quality engineering

Cross-functional teamwork

Problem solving

Communication skills

GMP/ISO regulations

Education

Bachelor's degree

Job description

As a Quality Engineer I you will utilize quality engineering principles, tools, and practices to develop, transfer and maintain products and processes throughout the product’s lifecycle, ensuring that products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements. In addition to this, you will use risk management and problem solving skills to prevent unanticipated failure modes and improve capability of products and processes through recommendation of preventive and corrective actions. Responsible for executing all items regarding quality issues, complaints, validations, and other projects in support of life science and/or clinical diagnostic product manufacturing.

How You’ll Make An Impact

• Providing engineering support to manufacturing and conducting the evaluation and disposition of nonconforming product and process-related issues using a risk-based approach to resolve problems impacting production fulfillment.
• Spending time on the manufacturing floor to identify process improvements, participating in investigations, root cause analyses, corrective action planning and implementation activities, and interfacing with cross-functional departments to improve product quality using recognized Six Sigma and Lean methodologies.
• Ensuring compliance with internal and external safety, quality, and regulatory requirements (e.g., FDA and ISO standards) by reviewing and approving product and quality system changes in partnership with Engineering and Manufacturing.
• Participating in Quality Review Boards, performing data analysis using appropriate statistical tools and techniques to identify trends, developing technical investigation plans, and recommending updates to quality standards and procedures as needed.
• Executing New Product Introduction (NPI) and Design Transfer activities by characterizing manufacturing processes for parts and components in development to ensure a successful transition from R&D to manufacturing, including participation in and leadership of equipment and process validation activities (FMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.

What You Bring

• Education: Bachelor's degree (BA/BS) or equivalent
• Work Experience: 0-2 years experience or equivalent combination of education and experience.
• Basic knowledge of and application of principles and theories of quality engineering.
• Ability to work well in fast paced and cross-functional teams.
• Excellent verbal and written communication, problem solving, analytical skills required.
• Understanding of GMP/ISO regulations and validation regulations is preferred.

Location

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'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.