Quality Assurance Associate

Summary

Assists in the development and coordination of effective implementation of quality/reliability goal-oriented programs supporting the pre-production, production and postproduction phases of operations, under guidance and supervision.

• Prepares quality plans, procedures and instructions in accordance with QA policies and requirements. Prepares appropriate documentation for quality control points throughout the manufacturing/assembly processes.
• Reviews manufacturing and assembly planning for appropriate sequenced quality requirements. Prepares appropriate quality control points throughout the manufacturing/assembly processes.
• Performs investigative research with discrepant materials and quality processes; compiles information, analyzes issues related to the root causes and initiates corrective action. Monitors and reports progress on failure analyses, corrective and preventive actions.
• Compiles, analyzes, and tracks corrective action plans and results of supplier and internal activities for effectiveness, and provides feedback and assistance where necessary.
• Performs problem analysis as to root cause and probable effective corrective action on complex products using statistical techniques and/or specific data as may be available.
• Compiles and analyzes relevant data and determines effective internal actions to correct and prevent product discrepancies which affect performance and reliability or otherwise do not meet valid customer expectations.
• Monitors and assists in the department material review activities to ensure that established quality objectives are being met and that adequate procedures and work instructions are in place and are being followed.
• Conducts or participates in internal quality audits, process/product improvement projects, product design reviews, supplier evaluation surveys, discrepant material review and disposition activities, failure analysis, and statistical evaluation/process control activities to resolve and prevent quality/reliability concerns.
• Assists with related special projects, as required.

• Three years quality related experience in manufacturing industry. Practical experience/training in quality planning, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem solving are highly desirable.
• Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, database manipulation and flow charts.
• Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations.
• This position interfaces with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job position.