|
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).
|
|
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.
|
