Quality Engineer II

As the Quality Engineer, II, you will support Bio-Rad’s commitment to quality and safety by evaluating and performing activities associated with the processes that make up the Quality Management System (QMS). This includes but is not limited to: nonconforming product management and assessment, customer or CAPA investigations, process control and monitoring, products transfer, supporting process or software validations, supporting product or process improvements, change control impact assessments, and risk management.

Location: This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office.

How You'll Make An Impact: 

• Analyze nonconformances, trend information, actual and potential cause of risks to identify and recommend corrective actions and control measures.
• Work closely with Engineering, R&D, QC, SQE and other departments with customer, CAPA, or NC investigations.
• Coordinate, support and review validation and risk management (dFMEA and/or pFMEA) activities.
• Support product improvement projects, process changes, and/or design transfer.
• May be assigned to other quality related tasks.

What You Bring:

• Bachelor’s degree or equivalent in a related technical discipline.
• At least 2 years’ experience in regulated manufacturing industry or equivalent combination of eduction and experience.
• Quality Engineering, Six Sigma Green or Black Belt Certification desirable.
• Basic understanding of risk management regulations, principles and application.
• Basic knowledge of and application of principles and theories of quality engineering.
• Advanced understanding of GMP/ISO regulations and validation regulations is preferred.
• Working knowledge of the device/drug/biotech manufacturing process.
• Skilled in statistical methods, stastical process controls and sampling plans.
• Communication, technical, and computer skills.
• Coordination, tact, and team work.
• Detailed-oriented and ability to multitask.

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 $86,600 - $119,200 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 also 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.

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-Hybrid