Quality Engineer II

Your responsibilities will include: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Collaborate with technicians and manufacturing engineers in assisting in identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material. Perform process validation and verification activities, including test method validation, and generate/review related documentation. Participates in team decision making and displays team problem solving/communication skills. Working with Project Management and Division teams to support new and updated products added to the area Process ownership and MRB support Provide support and mentorship to area Quality Technicians Bachelor's degree in engineering or science related field Minimum 2 years experience Experience in a regulated medical device industry, preferably in Quality Experience in Capital Equipment manufacturing Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering Prior experience with non-conforming material review process Experience in Validation, Statistical sampling and/or Root Cause Investigation Familiarity with product documentation, inspection and testing, and Manufacturing Execution Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.).