Quality Engineer I

Bio-Rad Laboratories•Woodinville, WA

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree or equivalent in a related scientific discipline.
0-2+ years experience or equivalent combination of education and experience.
Ability to work well in fast paced and cross-functional teams.

Nice To Haves

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.

Responsibilities

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.
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.