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Must have - FDA QA experience to include having successfully completed an FDA audit. In addition, lean six sigma black belt certification is required.The quality assurance control manager is responsible for delivering optimum quality for the companies goods and services as well as manages and coordinates activities and operations of quality control and assurance department and staff. In addition, maintains consistent quality and ensure compliance with laws, regulations, and environmental standards, recommending improvements where necessary.Manager also ensures incoming, in process and output production quality are following required specifications. Ensuring calibration activity and systems reliability testing are being practiced. To ensure all quality process and activity are conducted according to the test and quality plans.Technical FunctionsDesigns, develops, and implements comprehensive quality assurance programs.Defines and manages an end-to-end test environment including but not limited to selection of tools, methods, and process.Reviews and evaluates services to correct deficiencies and formulate improvements.Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate.Reviews, analyzes, and implements technological changes to enhance performance and customer requirements.Hires, trains, supervises, motivates, and develops quality assurance staff; manages schedules and workflow.Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.Keeps up to date on overall activities of the team, identifying problem areas and taking corrective (link removed)municates and resolves QA issues with operators/technicians on a day-to-day basis.Provides daily project status updates to management, as needed.Prioritizes and manages multiple projects within design specifications and budget restrictions.Develop and provide technical training for team, customers and peers.Accurately manage and log time worked by project code daily.Responsible for meeting and facilitating product release (link removed)vestigates and thoroughly understands developments in quality assurance codes and standards.Responsible for overseeing the development of and maintain up to date internal staff (link removed)bound and outbound service and support calls through phone and email communication.Gain understanding of the client's needs and requirements and communicating them and the quality standards to the production teams.Devising ways to improve the manufacturing process to ensure higher-quality goods.Keeping accurate documentation and performing statistical analysis.Gaining feedback from the clients, attending meetings, submitting reports, and assisting external auditors and (link removed)specting the final output, comparing it to the requirements, and approving or rejecting the final products.Process FunctionsCoordinates with other managers and associates to identify critical success factors, develop measurement systems, and implement continuous process improvement methodologies.Maintains, enforces, and measures quality assurance processes.Assures on-time delivery of products; ensures product quality, performance, and conformity with company established (link removed)rries out supervisory responsibilities in accordance with the organization's policies and applicable laws.Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.Six Sigma and ISO:9001 processes are to be understood and followed per Company Quality Management System.Track all customer related service and inventoried products via CRM/ERP software.Devising, improving, and reviewing new specifications and procedures for products or processes, and training staff to use them.Setting the requirements for raw materials from suppliers and monitoring their compliance.Supervising inspectors, technicians, and other staff members and providing guidance.Ensuring legal obligations are followed and ensuring compliance with regulatory bodies and with health and safety guidelines.Overseeing product development procedures to identify any deviations from quality standards.Maintain detailed and accurate product reporting of each product issue or inquiry utilizing EPR (Epicor) system.Collaborate with company personnel to provide prompt resolutions for customer inquiries or issues.Maintains and manages department budget as required and directed by VP of Operations.Performs other duties as requested or assigned to better the department or company.Job Knowledge, Skills, And AbilitiesIn-depth understanding of Six Sigma and ISO 9001 processes.QA Manager in manufacturing, Six Sigma green belt or higher, FDA experience having gone through an FDA auditAble to prioritize work, manage time effectively and work successfully in a fast paced, multi-faceted structured environmentStrong communication skills including the ability to teach others how to operate complex systems and equipment.Experience with ERP/Service Management SoftwareStrong mechanical skills and knowledge of electrical and mechanical principlesStrong technical skills including knowledge of assembling, testing, and troubleshooting computers (hardware and software), audio/video equipment, and mechanical devicesKnowledge of and ability to troubleshoot Microsoft Windows OS platform issuesExperience with PC NetworkingExperience with tools, both manual and powerUnderstanding of firearms and firearm safety.