DQA expert社

面议

市辖区本科及以上7年及以上

发布时间：2023-09-06

职位描述

Tasks performed regularly which form the essential characteristics of DQA AP position
· Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs.
· Provides Training on design & development relevant quality requirements (regulatory requirements and FMC SOPs as well as CDC specific SOPs).
· Provides input to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Design Quality.
· Review and approve all product development and change management projects with respect to compliance with Fresenius/CDC Quality Management System / SOP requirements by:
ü Review and approval of design control documentation
ü Design Review, Phase Exit Review and Milestone approval
ü Sample review of design control documentation during project execution
ü Independent compliance check through regular corporate audits
· Quality Approver for Design and Development related NC/CAPAs.

Tasks performed regularly which form the essential characteristics of process owner of subsystems of CDC QMS.
· Lead oneQ introduction in CDC.
· Drive lean CDC QMS concept and planning overall.
Proactively manage QMS sub-systems and guarantee all the processes under assigned sub-systems compliance to applicable regulatory requirements as well as CQMS processes by:
ü Set up an effective NC and CAPA process and ensure NC and CAPA process running smoothly in CDC
ü Set up an effective supplementary QMS documentation management processes (including quality record management) and ensure they are working well in CDC
ü Set up an effective QMS reporting system and ensure all QMS KPIs are well set and monitored in defined intervals, applicable actions are taken timely to mitigate the risks of process non-compliance
· QMS planning for the assigned sub-processes if any creation, revise, obsoleted as well as specially optimized to meet the latest regulatory and business requirements.
· As a leading process owner from GMQS AP DQA team, shall organize other process owners to maintain QMS key process more effectively and continuously improve CDC QMS.
· Lead an effective CDC internal audit and support CDC external audit.
· Perform the QMS trainings (part of orientation) and monitor all planned QMS trainings (LPOs are the owners) are completed in an effective way.
· LIR of assigned CQMS DCC Packs: Evaluation and Implementation.
· DQA Responsible for supplier quality management of assigned project and CDC supporting functions.
Cooperate closely with CDC DCC.

其他要求

招聘人数：1人
职能类别：医疗器械生产

公司介绍

费森尤斯集团作为世界五百强企业之一，是全球性的医疗保健服务公司。公司以优质的医疗产品和可信赖的治疗服务享誉全球。费森尤斯研发中心，涵盖研发、知识产权、质量管理、注册、工程等部门，汇集全球研发精英。