QS Engineer - Leetsdale, PA

Key Characteristics:
-Responsible for developing and coordinating implementation of quality systems (SPC), procedures, test methods, problem definitions and resolutions for existing and new products, including;
-Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use.
-May be required to have specific product or process expertise to fit business needs
-Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with our company's SOPs and regulatory standards.
-May lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence.  Use of TQM tools including six sigma is required. 
-Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects and supplier changes to ensure qualification are met. Will have direct customer interaction.
-Conducts internal or external audits as assigned to ensure compliance to company quality system requirements.
-Maintains records to ensure compliance to GMP/ISO requirements.

Education and Experience Required:
-Bachelors degree in an Engineering or Life Science discipline or related technical field
-4+ years work experience for QS engineer I, or 7+ for QS Engineer II
-Computer knowledge and experience with Microsoft Office
-Good written and oral skills
-SPC knowledge, implementation experience preferred
-Product and process rick assessment required
-Strong attention to detail
-Six Sigma certification, Black Belt preferred
-Must have expereince with medical device manufacturers

Six Sigma, Black Belt preferred
SPC experience, implementation preferred
Product/Process Risk Assesment knowledge
Medical Device Industry
FDA regulated