Senior Supplier Quality Engineer

Job Description:The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service.Roles and Responsibilities:Part QualificationSupport Value Engineering and Quality Improvement Part Qualification effortsLead Core Product Teams in defining appropriate Part Qualification requirementsThis includes defining testing and inspection requirements prior to system integration to maximize ISI factory efficiencySupport transfer of parts between suppliersComplete Production Part Qualification Process deliverables: Supplier pFMEA, Special Process Validations, FAI, and Process Capability AnalysisPerform product/process risk analysis and ensure mitigations are implemented and effective prior to product introductionEstablish sustainable process capability at supplier and critical sub-tier suppliersSupport Manufacturing Line Escalations from manufacturing teamsDrive corrective actions through use of various Root Cause tools (8D, 5 Why, etc), determining true root cause, implementing effective and lasting corrective and preventive actionsManufacturing Process Selection and DevelopmentLead manufacturing process selectionIdentify the correct process for manufacturing the part, considering process quality, long term capacity and total lifecycle cost.Identify where DFM is appropriate to achieve higher quality, lower costs or better supply chain capacityEducate internal customers and suppliers regarding supplier quality, process and operational capabilities, best value manufacturing methods and tooling for key supplier processesManage changeDrive improvements to ISI requirements as necessary by proposing and managing changes to specifications and drawings through the ECO processManage the planning and implementation of supplier change management projects using the Supplier Change Request process (SCR) post Design V&VProvide status of the readiness (quality, capacity, delivery) of the supply chain for major production process changesWork cross-functionally to improve supplier engineering processesSupplier Selection and EvaluationSupport Supplier SelectionWork with Product Design, Commodity Mangers and other stake holders to identify high capability suppliers necessary for New Products based on assessment of business need and supplier capability.Evaluate new supplies through informal assessments and formal assessment by supporting lead auditors in QMS evaluationsFoster Supplier RelationshipsSupport audit team in addressing findings to develop suppliers' quality and business systems in order to meet ISI's requirementsManage supplier relationships to effectively partner with ISI suppliersSkill/Job Requirements: In order to adequately perform the responsibilities of this position the individual must possess:BS degree in Engineering field10 years related experience in Manufacturing, Supplier Process Engineering, Design, or related fieldExcellent written and verbal communication skillsExperience creating and aggregating DFM feedbackDemonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilitiesExperience with a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacityDesired product experience in the following categories:Machining, including 4 & 5-axis holdings, FMS and bar-fed lathesMetal Fabrication, Welding and/or other bonding processesPlastic Injection Molding or other plastic forming processesDie casting or ThixomoldingMechanical Motion Products (Bearings, Gears and Screws)Mechanical Motion Control Products (Motors, Brakes)Motion Control Sensors (Encoders, Inertial Sensors, Resolvers)Medical Gas Line ProcessingProven ability to motivate suppliers and lead teams to solve difficult technical and process problemsKnowledge of pFMEA, process validation, inspection and test techniquesFamiliarity with 21 CFR part 820 and ISO 13485Experience in auditing suppliers to these standards is preferredAt a minimum, candidate should understand GDP and QMS methodsSignificant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAPAbility to read and interpret detailed specifications and schematics and communicate technical informationExperience in a medical device company is a preferredExperience with low-volume high-mix production environments is a preferredAbility to travel to suppliers on an as needed basis – domestic and international