Description:

The Quality Assurance Specialist is responsible for ensuring products and processes meet quality standards through validation activities, quality investigations, complaint handling, process monitoring, and continuous improvement initiatives. This role partners closely with production, engineering, suppliers, and product development teams to drive compliance, root cause analysis, process validation, and the implementation of quality systems using tools such as Six Sigma, SPC, PFMEA, and process capability studies.

Essential Functions:

+ Participates in the change control process and assures proposed changes are compliant to the quality system requirements.

+ Performs and approves IQs, OQs and PQs of manufacturing, purchasing and test documentation to ensure fulfillment of quality requirements. Oversees clean room environments, including qualification and monitoring.

+ Reviews inspection criteria, inspection methods and procedu...