Quality Engineer II

Position Summary

The Quality Engineer II develops, implements, and improves commercial product quality requirements, and is committed to improving the quality of patient care and improving the effectiveness of the quality management system. As a high level and hands-on resource, this position leverages medical device quality, supplier and manufacturing experience to lead sustaining risk management activities, support root cause analysis, and provide technical support for process verification and validation activities.

Job Duties/Responsibilities

• Collaborate with cross-functional team (including Supply Chain, Manufacturing, Suppliers, Regulatory, etc.) to communicate, understand and solve quality problems.
• Evaluate product quality risks and acceptability of nonconforming materials
• Develops, maintains and evaluates risk management file including supporting FMEAs
• Provides investigative support for product quality issues.
• Utilize root cause analysis techniques to identify potential solutions to address those root causes within the corrective and preventive action system.
• Drive continuous improvements through observation, measurement and root cause analysis.
• Perform statistical analysis in support of root cause analysis, process control, and verification and validation activities.
• Develop new processes which support speed, cost reductions and quality improvements.
• Develop process validation requirements (IQ, OQ, PQ) and equipment qualifications.
• Manage the selection, qualification, and certification of responsible suppliers to provide materials that meet specifications for production requirements.
• Maintain supplier relationships that encourage technical input and contributions, as requested, concerning new products, processes, ideas, and improvements. Initiate actions required to maintain the supplier performance at high level.
• Adheres to the Company’s purpose operating principles, building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned.