Job Description

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 procedures based on acceptable quality standards. Conducts technical and statistical investigations on quality problems. Recommends and assists in implementing manufacturing improvements based on quality investigations.
•  Evaluates customer complaints to identify failure trends. Participates in Investigation of product complaints and assures implementation and documentation of corrective actions. Conducts root-cause analysis as assigned relating to customer complaint and product returns.
•  Works with product development, Tech services and production during product transfer to ensure quality deliverables (PFMEA, Control Plans, Inspection Plan, Inspection Equipment and Tooling) are in place. Conducts engineering studies related to Gage R&R, Cpk, SPC and Process Validation.
•  Utilizes Six Sigma, SPC and other quality took to implement process improvements, enhance product quality and reduce process variance. Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.). Evaluate quality control test results for trend analysis. Identifies areas of systematic weakness, and leads to initiatives to implement corrective action. Presents this information to management, supervisors, and manufacturing operators.
•  Provides technical and quality support to suppliers.

Additional Responsibilities:

•  Assists in Annual Product Review.
•  Conducts audits of processes and analyze statistical data to facilitate Continuous Improvement.
•  Acts as a quality representative for material review board (MRB).