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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.
Job Responsibility:
Attend cross functional Daily Management meetings and represent Quality Assurance following up on blocking issues and implementing counter measures
Manage the Material Review Board and ensure thorough data-driven documentation of non-conformities and risk based determination of CAPA
Review data for trends, manage corrections and corrective action and support Global Supply Chain and business partners as requested
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
Demonstrate focus and accountability by attending Daily Management and consistently meeting commitments with timeliness and reliability
Facilitate risk management practices and ensure all quality requirements are satisfied
Requirements:
Bachelor’s degree or equivalent in a related scientific discipline
0-2+ years experience or equivalent combination of education and experience
Ability to apply GMP / ISO regulations and validation principles in a regulated manufacturing environment preferred
Basic 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
Nice to have:
Ability to apply GMP / ISO regulations and validation principles in a regulated manufacturing environment preferred
Quality Engineering, Six Sigma Green Belt Certifications desirable
Skilled in statistical methods, statistical process control and experimental design preferred