Quality Engineer II

Job Summary

The Quality Engineer, as part of a cross-functional team, with primary responsibility for quality management related to Operational support, ensures that applicable elements of the Quality System and external standards are being followed. As the voice of Quality, the Quality Engineer applies quality best-practices including team-based and statistical tools and techniques, strong root cause analysis skills, and promotes the value and use of such tools throughout the organization. This role will lead and execute projects of varying complexity and must be able to connect well with all levels of the organization from operators and inspectors to management. The role should require minimal oversight from management and possess strong root cause analysis skills.

Essential Job Functions

• Executes Quality Engineering activities in relation to Operational support, including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities.
• Performs root cause analysis of identified issues and identifies appropriate corrective and preventive action. Supports NC and Complaints/CAPA/SCAR systems within QE Team.
• Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making.
• Supports activities related to clean room monitoring and environmental controls.
• Works closely with Quality Control team to ensure adequate resources to support manufacturing
• Ensures compliance with all practices in accordance with the Quality Management System.
• Provides technical support for process improvements, supplier changes or design changes including but not limited to creation or updates to risk management documentation, ensuring comprehensive documentation is available, adequate records are produced, and change management is implemented for such changes.
• Work with quality control, manufacturing, and warehouse personnel to implement processes and process improvements including related documentation
• Executes control measures and drives resolution when supplier quality issues are identified.
• Supports supplier management principles such as supplier selection, qualification, certification, and performance improvement.
• Applies the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interprets and selects variable, attribute, and zero-defect sampling plans. Supports incoming inspection processes.
• Develops and validates test methods with oversight as needed. Identifies and applies metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conducts measurement system error studies such as Gage R&R.
• Understands the implementation of appropriate internal, national, and international requirements and standards. Performs internal and external audits as necessary (virtual and in-person) including supplier audits
• Defines, identifies, and applies product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions.
• Contributes to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description.