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Quality Engineer II

  • 2025-37077
  • Woodinville, Washington, United States
  • Qualidade e Regulatório
  • Essencial (no local)

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 lead risk management activities in order to continuosly improve proceeses through development of risk-driven strategies for validation and targeted control 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.
  • Develop, maintain, and continuously improve manufacturing processes through validation of products and processes. Conduct risk assessments to identify critical to quality attributes, process parameters, and material attributes in order to determine validation strategies.
  • 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 $82,000 - $95,000 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-PB     

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.

 

 

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