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Job description (Tasks/Responsibilities):
Apply
data driven analysis and systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality issues. Drive/Lead
advanced quality planning and production part approval process for assigned
commodities. Plan and execute equipment qualification and process validation. Ensure
compliance to purchasing controls processes, regulatory, and external
standards. Communicate global sourcing requirements to program team to ensure
quality and schedule goals are met. Ensure early supplier involvement in the
new product commercialization process. Team cross-functionally to ensure DFx
(DFMA: Design for Manufacture & Assembly), Test, Service. Coordinate test
development activities to ensure electronic assemblies meet customer
requirements (e.g., drive test correlation between component level and system
level performance). Proactively identify risk / issues (from virtual analysis
through build events) which may adversely affect quality. Administer supplier
corrective/preventative actions in a timely and effective manner. Lead supplier
process capability programs for new component, processes, assemblies or
purchased finished goods. Drive Continuous improvement at suppliers by managing
defined quality initiatives. Participate in Quarterly Business Review for
assigned suppliers' lead the quality section of this review. Lead Supplier
audits to ensure conformity to contractual requirements as well as quality
system compliance Drive assigned suppliers to 100 DPPM or less -Instill a zero
defect mindset. Team with global sourcing commodity managers and purchasing
engineers (i.e., provide input for supplier selection activities including
supplier evaluation and Quality Systems Audits). Review and approve all
Supplier Quality Requirement Plans (SQRs) and develops follow-up after
implementation. Perform Quality Systems and Process Audits of current suppliers
including reporting, follow-up and closure of nonconformance. Ensure timely
disposition of non-conforming material -analyze defect trends in order to
initiate appropriate corrective action.
Skill Requirements:
B.S. in a technical field of study, or equivalent; MS Engineering, MBA,
ASQ CQE are desired. 10+ years experience in supplier quality or combination of
manufacturing engineering, quality, product development. Knowledge of Six Sigma
methods (green belt or higher). Medical device industry experience. Experience
with Electronic Components / Electronic Devices & High Volume
Manufacturing. Experience troubleshooting manufacturing process and product
problems for Electro-Mechanical subassemblies. Experience facilitating process
Failure Modes and Effects Analysis (FMEA), Control Plans, SPC, Capability
Studies, DOE, Gage R&R. Experience developing pre-production control plans
desired. Quality systems auditing experience in a medical device manufacturing
environment. Experience in supplier management. Up to 30% domestic and possible
international travel and the ability to travel on short notice.
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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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