Quality Engineer II

1 week ago


Woodinville, United States Bio-Rad Laboratories Full time

Join Bio-Rad as our Quality Engineer and work in our Woodinville, WA site Working in this Quality Assurance role, you will attend cross functional Daily Management meetings and represent Quality Assurance following up on blocking issues and implementing counter measures. You will manage the Material Review Board and ensure thorough data-driven documentation of non-conformities and risk based determination of CAPA. You will review data for trends, manage corrections and corrective action and support Global Supply Chain and business partners as requested. How You'll Make An Impact: Improve the overall efficiency of the Quality Management System by launching initiatives to prevent deviation recurrence by analyzing nonconformances and complaints for trends. Support release of high-quality product by managing the Material Review Board and making risk-based and compliant decisions. Maintain the integrity of the Quality Management System by ensuring investigations are well designed, executed and documented. Provide confidence to internal and external customers by following through on actions, continually improving processes, and promoting quality culture. Facilitate risk management practices and ensure all quality requirements are satisfied. What You Bring: Bachelor's degree or equivalent in a related scientific discipline. 2+ years experience or equivalent combination of education and experience. Ability to apply GMP / ISO regulations and validation principles in a regulated manufacturing environment. Understanding of risk management best practices and regulations for the medical device industry. Quality Engineering, Six Sigma Green Belt Certifications desirable. Skilled in statistical methods, statistical process control and experimental design preferred. Ability to work well in fast paced and cross-functional teams. 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 $78,600 to $108,200 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 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. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Her


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