Quality Engineer I

Location: Woodinville, WA (100% On-Site)

7-Month Assignment (potential to extend)

Pay: $32-34/ HR

Our client, a developer and manufacturer specializing in technological products for the life science research and clinical diagnostics markets, is seeking a Quality Engineer I to join their team. The candidate will attend cross function Daily Management meetings and represent QA following up on blocking issues and implementing counter measures. Additionally, you will manage the Material Review Board and ensure thorough documentation of non-conformities and risk-based determination of CAPA.

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 products by managing the MRB and making risk-based and compliant decisions.

Review data for trends, manage corrections and corrective action and support GSC and business partners as requested.

• Maintain the integrity of the QMS by ensuring investigations are well designed, executed and documented.
• Provide confidence to internal and external customers by following through on actions and continually improving processes.
• Facilitate risk management practices and ensure all quality requirements are satisfied.

What You Bring:

• Bachelor’s degree or equivalent in a related scientific discipline. 0-2+ years’ experience or equivalent combination of education and experience.
• Strong understanding of GMP / ISO regulations and validation principles 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.

Please submit your resume in Word or PDF format to be considered.