JOB TITLE: Quality Assurance Manager JOB DESCRIPTION: The Quality Assurance Manager responsibilities are to insure that the delivered product and service quality are in full compliance to Oticon Inc. standards and meet the customer’s expectation. This individual is responsible for developing and implementing internal quality procedures for hearing aids and accessories as well as driving a continuous improvement philosophy throughout the operation. This individual will communicate directly with customers (audiologists) to determine if the delivered products meet their performance and cosmetic requirements. They will summarize data outlining the quality perceptions and present it to Oticon Inc. as well as corporate management along with recommendations for improvement. Routine job functions: Insures ISO compliance in the operations area; Insure compliance to applicable FDA/GMP guidelines. Verify adequacy of testing capacity and coordinate Quality Control Audit/ Testing daily activity and track performance. Develop statistically based sampling plans and perform statistical analysis on internal defects to identify cause and drive corrective action. Drive improvement in quality testing, leading edge techniques to reduce time, improve accuracy and improve workflow. Perform statistical analysis on quality performance/compliance to management and recommendation for improvement. Monitor subcontractor performance to Oticon Inc. quality standards and customer satisfaction;Tracks product deficiencies and reports to the Quality Group at Oticon A/S. Must be able to perform customer visits to assess overall satisfaction with Oticon products from a performance perspective and validate if customers expectations are met; Maintains and updates all documentation changes from Oticon A/S. Drives implementation of new production methods and products. Act as liaison in quality matters between Oticon Inc. and A/S, and be the customer’s internal representative. This position reports to the Vice President of Operations and requires a Bachelor`s degree in the sciences, ASQ certification a plus.