某知名医疗器械公司
R&D Engineer
生命科学
生命科学
上海
经验不限
本科
面议
职位描述
• Complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis
• Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation
• Select the right process and supplier for the part, considering long term fit and total cost of ownership
• Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations
• Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process
• Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation
• Effectively prioritize and advance multiple concurrent projects and tasks
• Clearly communicate project status to key stakeholders
• Build, own, and relentlessly pursue a vision for developing suppliers
• Understand proper level of documentation detail for tracking of actions and justification of decisions
• Generate key metrics for the team and suppliers, and continually drive for timely achievement of those metrics
咨询顾问
Delilia Li
Team Manager
分享