APU Quality Control Manager

Position Purpose: Plan, coordinate and manage through completion, assigned projects designed to ensure continuous production and distribution of products consistent with established standards.  Supervise and coordinate the activities of Quality staff. Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures, and standards. Duties and responsibilities are accomplished personally or through subordinate staff.KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS: Coordinate and execute objectives throughout the company in cooperation with other managers, to maximize product quality and operating system efficiency/effectiveness to minimize costsIdentify and coordinate resolution of system(s) inefficiencies that contribute to increased quality costsCoordinate the execution of validations, including creation of written protocolsCoordinate the execution and participates in elements of investigations regarding customer complaintsAssesses results of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to FDA regulatory, ISO and Customer requirementsEnsures CAPA system is effective and utilizes problem solving techniques to reduce internal and external failures. Ensures sound techniques are applied (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively. Assesses results for application, validity, and conformance to specificationAnalyzes data in relationship to assigned projects to determine adequacy of present standards and establish proposed quality improvements. This includes analysis of current inspection methods and sample plans.Plans, promotes, performs, and organizes training activities for internal departments and customers, related to quality activities which include basic statistics, DOE, GR&R, Sample Plan designation, validation creation, control and oversightInteracts with customers to assure mutual interpretation of specified requirements to ensure fulfillment of customer requirements and objectives are metEnsures ISO and FDA QSR quality systems complianceGenerates and provides monthly and weekly reports as requiredExecutes specific responsibilities as defined within the company quality operating systemSupports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiativeReview and approve various document as defined in the established QMSResponsible for the coordination and evaluation of the Quality departmentCarries out supervisory responsibilities, in accordance with the organization’s policies and applicable laws. Participates in interviewing, hiring, and training employees: planning assigning and directing tasks, apprising performance, rewording, and disciplining employees, addressing complaints, and resolving problemsRepresent the Quality Department in support of customer and ISO auditsOther duties as assigned