Quality Assurance Manager

Quality Manager will plan, coordinate, and direct quality management (ISO 13485) systems to ensure quality control and quality assurance of the design and manufacture of plastic injection molded medical devices consistent with established standards. Advise on, supervise, and perform administrative and technical work primarily concerned with the assurance and inspection of material, products, and processes for conformance with established specifications and standards as well as compliance with regulatory specifications and standards Be responsible for verifying the final quality of products on the production line and also separating those that do not have the desired technical specification, through checking with measurement instruments or equipment, aiming to follow the norms and standards of quality defined by the company Conduct nondestructive examination (NDE) and quality control (QC) inspections on products, materials, components, parts, etc., at various stages of the production process to ensure compliance with established quality and reliability standards Capture and analyze statistical data from processes to either confirm compliance with established standards or identify deviations from standards Recommend new or enhanced methods, procedures and standards. Require technical or managerial knowledge and ability, plus a practical knowledge of quality assurance and control concepts and systems Provide work leadership and training to ensure policies, practices, and procedures are understood and adhered to Resolve quality issues by conferring with management and other departments Develop and maintain the Quality roadmap as well as departmental processes and Quality standards Coordinate Quality audits and administrative duties Develop and implement key measurables to drive and ensure that the business objectives are achieved continuous improvement initiatives within the Quality team Plan or develop applications or modifications for products or systems to improve and drive Quality performance Participate in the hiring process by screening candidates and conducting interviews Maintain a strong working knowledge of the functionality of all quality approaches by continually learning and implementing best practices Ensure alignment between local level activity and overall business strategy Supervise Quality Technicians and Quality Engineer Qualifications Bachelors degree in Engineering or related field and a minimum of five years of Quality experience in a production/manufacturing environment is preferred. Will also consider an associate degree in Engineering or related field or equivalent experienc ISO 13485 (Medical Devices) experience required Plastic injection molding or other plastic experienc #J-18808-Ljbffr