The Quality Engineer supports, evaluate and performs activities associated with processes that make up the Quality Management System (QMS). This includes but is not limited to: nonconforming product management and assessment, customer complaints investigation, process control and monitoring, process/equipment change control assessment, Products Transfer, Supporting process validation, and risk management.
How You’ll Make an Impact:
- Facilitate and manage customer complaints that escalate to Manufacturing for investigation
- Work closely with Engineering, Quality Control, SQE for complaints investigation
- Track and monitor complaint investigation until closure
- Support and review Process validation activities and risk management, pFMEA
- Identifies and analyzes actual and potential causes of risk, consequences and control measures and may approve basic to moderately complex investigations, corrective actions.
- Analyzes nonconformances, complaints and trend information to identify and recommend corrective actions and basic application of statistical tools and methods.
- Conducts more in analysis, research as assigned.
- Supports product improvement projects and process changes to ensure validation requirements are met.
- May be assigned basic/simple projects or assignments
What You Bring:
While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.
- Bachelor’s degree or equivalent in a related technical discipline
- Quality Engineering, Six Sigma Green or Black Belt Certification desirable
- At least 2 years’ experience or equivalent combination of education and experience.
- 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, statistical process control and sampling plans.
- Basic understanding of risk management regulations, principles and application.
- Strong communication, technical proficiency, and computer literacy.
- Excellent coordination abilities, tactfulness, and capacity for effective teamwork.
- Preference given to candidates with strong manual dexterity
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 our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our 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 comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations 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.
