Experience Requirements
A minimum of 2-4 years related (medical device, pharmaceutical preferred) experience ASQ CQA or CQE preferred; 6 Sigma experience preferred. Engineering experience in manufacturing operations, including new product development, cost reduction, process qualification, and quality engineering.
Qualification Requirements
This individual must thoroughly understand fundamentals of quality systems, quality standards, inspection techniques, and supplier development. Also, leads in development of inspection processes for Class I and Class II medical devices. Effectively communicates the company's quality objectives and engineering/manufacturing requirements to suppliers. Performs other related duties as required.
Preferred Qualifications
A.S. degree in Engineering (industrial, mechanical, chemical, etc) or closely related field required, Bachelor's of Science degree preferred.
Responsibilities
This position is accountable for a broad range of technical assignments in the quality assurance area under limited supervision to include investigating problems and developing disposition and corrective actions for NCMR's, leading and tracking for the CAPA system, and Management Review planning and execution, and Complaint Investigations.
Home
