Manager of Supplier Quality Assurance

Breathe Life Into Your Career Respironics, a worldwide leader at anticipating needs and providing valued solutions to the sleep and respiratory markets. The company's focus is on home care, hospital, respiratory drug delivery and international markets providing programs that manage sleep disordered breathing, chronic obstructive pulmonary disease, asthma, infant care, congestive heart failure and restrictive lung disorders. Globally positioned has manufacturing facilities in several domestic and international markets. We have an immediate opportunity in our Pittsburgh, PA territory for:Manager of Supplier Quality Assurance Responsibilities: Provide supplied material and service solutions at the optimal value for our internal customers. Lead supplier performance measurement, process validation, training, corrective action and continuous improvement efforts to ensure suppliers meet performance requirements in quality and service throughout the product life-cycle. Continuously improve the current supplied material qualification process in order to yield improved PPM levels of devices post launch. Develop a comprehensive supplier quality management system that complies with all regulations, is lean in its construction, and yields improved quality performance of the supply base. Develop Supplier Quality Engineers and Technicians, as well as establishing the staff structure and setting priorities that facilitate effective supplier management. Assure that Supplier and Material Qualification processes are built into the Respironics New Product Commercialization process. Work with Global Sourcing Commodity Management and Business Segment Management groups to assure that new and existing suppliers meet applicable requirements. Primary contact in Global Sourcing organization for all Management Reviews, Internal and External Audits. Provide supplier assessment and supplier quality management to support business development acquisition plans. Ensure that the Supplier Quality program complies with all applicable regulatory requirements, including: FDA, ISO, CMDCAS, etc. Requirements: BS degree in Engineering or BS degree in related discipline. Master of Science degree or Master of Business Administration desired. ASQ Certified Quality Auditor and/or ASQ Certified Quality Engineer highly desired. 15 years experience in a manufacturing environment with a minimum of 10 years quality management experience in a regulated industry required. A minimum of 5 years quality management in the medical device industry required. A minimum of 10 years experience in supplier management required. 5+ years conducting supplier audits in compliance with ISO and FDA regulations required Comprehensive use and understanding of FDA GMPs, ISO 9001, ISO 13485, ISO 14971, and other regulatory requirements for medical devices Demonstrated experience designing/implementing a lean supplier quality management system in compliance with ISO13485, and FDA QSR required. Demonstrated experience implementing process validation methodologies on supplied components required. Demonstrated experience improving quality at suppliers through the use of quality tools and practices required Demonstrated ability to work with procurement leaders to improve supplier performance required Domestic and international travel will be required (20% of the time) .At Respironics Inc., our products improve the lives of patients with a variety of respiratory needs in the hospital, homecare, critical care and neonatal environments. To learn more about our organization, our products and our culture… please apply online and reference job number: 1584BR.Your interest in our company is appreciated however, only candidates considered for interview selection will be notified. AA/EOE.www.respironics.com Apply Online: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=25012&siteid=5146&AReq=1584BR&Codes=MON