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What a typical day looks like: Hold a key engineering position, affecting supplier quality and support in update and implementation of Health Solutions (HS) Corporate systems and procedures.Regional responsibilities --- Support implementation of Health Solutions Corporate procedures and systems at the regional level.Regional SME - Working as SME (Subject Matter Expert) to manage, develop and support Supplier Quality Engineering teams at site and regional level. Drive compliance with company policies/procedures, ISO 9001, ISO 13485, FDA QSRs, EU MDR, and other applicable standards.Identify, define, drive, and support strategic initiatives for Supplier Quality Engineering.Develop and maintain strong relationship with internal stakeholders such as Site Quality, Corporate Quality, NPI, Procrurement and external suppliers.Material (Component) Qualification---Implement PPAP (FAI). PPAP include FAI, Material Certificates, Quality/Process Control Plan, FMEA, MSA, Process Parameter Sheet, RoHS compliance, Reliability Test, COC, etc.Pilot Run Tracking---Track the new qualified parts quality performance to ensure meet the customer quality requirements in pilot run phase. Drive supplier corrective action from supplier in Pilot Runs (1-3 lots) and smoothly transfer the pilot run to mass production.Hot Issue Solution and Trouble Shooting--- Working as SME (Subject Matter Expert) to support on supplier quality hot issue and trouble shooting.The experience we’re looking to add to our team: Min 4 related working experience is required (2 and above years’ working experience in medical will be plus)ISO 13485 Lead auditor certificationsUnderstanding of FDA CFR Part 820 and cGMP requirementsSix Sigma, Lean, or ASQ Certification and trainings is a plusWorking knowledge of product risk management standards and tools (e.g. ISO 14971, FMEA) Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.Test method validation and gage R