Quality Engineer

Description:

• 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:

• 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.

What You Bring:

• 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.