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Job description (Tasks/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.
Skill 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) .
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Company Description:
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.
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