职位描述
职位描述: 职责描述:Be the core team of design control process and ensure product design quality.Design Control of quality function:-Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.-Leader to ensure robust verification & validation, and transfer of product designs are established.-Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems.-Review technical document and product specification.Verification and Validation:-Expert in verification and validation procedures and approaches for robust qualification of product and process designs.-Provide quality approvals of plans, procedures, and reports for verification and validation activities and ensure robust justification of all protocol deviations and non-conformances.Regulatory:-Provide guidance on compliance requirements for ISO, MDD, QSR & SFDA regulations.-Partner with regulatory experts for initial regulatory review in support of design change request.-Support CE and or FDA technical documents submitting.Quality Engineering:-Provide expert statistical support for DOE (Design of Experiments), sampling plans capability assessments hypothesis tests.-Provide reliability/stability objectives & assessment plans.-Support risk assessment activities: FMEA, FTA.Project Quality:-Act as QA window and communicate with customer quality for product technical discussion.-Facilitate new products/customer launches form quality control point of view.任职要求:Bachelor or above in engineering or scientific disciplineBilingual: English/Mandarin requiredQuality assertiveness and quality mindedness.Project management – support multiple projects simultaneously.Organizational – can synthesize information from a variety of sources>3 years as Design quality 职能类别: 体系工程师 医疗器械生产/质量管理 关键字: 设计质量