Product industrialization Engineer

Shenzhen, Guangdong
Permanent
Full-time

25 days ago

Job Title Product industrialization EngineerJob DescriptionPosition: Product industrialization EngineerKey Responsibilities:PI Engineer for the Clinical Applications and Devices Consumables portfolioExecuting to the Supply Chain responsibility priorities: • Prioritize and address any Safety related issuesImprove the teams execution of Regulation and QMSR Compliance thru 100% training compliance, continuous monitoring of product quality. • Focus on Product Quality - Actively identify, investigate, and address quality issues with impact the customer via DOA, DEFOA, for product on time shipmentsPractice a continuous improvement mind set with a focus on LEAN business processes, manufacturing processes, and communications. Monitor yield and supplier quality performance to reduce the cost of non-quality of materials and/or operational executionWork with supplier, commodity manager, and procurement engineering to improve OEM or contract manufacture quality with improvement of product quality, SCAR-supplier corrective action records and documented actionsProactively engage with the assigned business category operational excellence priorities, business objectives, and NPI initiativesCollaborate and participate in identifying and implementing cost savings programs such as BOM Cost Savings and productivity of business processesIdentify your individual opportunities to strengthen your own skill set to further engage and constructively challenge the performance of the team.Works as an integrator together with experts and stakeholders from in- and outside the Supply Chain management function, including Quality & Regulatory and IT.Understand systems, master data, and data architecture to pull data from numerous tables and from multiple sources to be merged and analyzed.Facilitate data mapping and data verification sessions.Collaborate with business stakeholders and based on findings submit recommendations(s) for business processes.Provide input to documented business and data requirements (URS and FRS) and create/update business processes / QMS documents within the Supply Chain.Support UAT Testing.Create/Update/Support TrainingAssist and lead continuous improvement through Lean methodologiesEstablishing appropriate methods, tools, equipment, etc. required to produce products in keeping with the Quality Management System and related stands (ISO 13485:2003 and GMP).Perform other duties as required to support the needs of the businessRequirements:BS Engineering discipline or technical field (MBA with concentration in Operations – preferred)5+ years of experience in Supply Chain and OperationsExperience with ERP applications and data repositoriesFamiliarity with Process, Master Data, IT infrastructure, QMS and Product LabellingGeneral understanding of product development process and design control.Ability to build highly effective teamsAbility to work in a cross functional environment at remote locationsStrong interpersonal and communication skills requiredMethodical, effective troubleshooting/problem solving skills requiredExperience IQ, OQ, PQ Validation Strategies preferredExperience with FDA-regulated medical device manufacturing in a Lean production environment preferredExperience with Microsoft Office tools requiredHow we work together
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