Job Responsibilities:
1.Lead the development, optimization, enhancement, implementation, and operation of the Quality Management System (QMS) in compliance with medical device regulations.
2.Manage QMS documentation and records, including design change controls, document change management, and record retention.
3.Plan and conduct internal audits: Develop audit schedules, lead audit teams, track non-conformities to closure, and manage internal auditor qualifications.
4.Manage external documents: Identify, collect, control, and implement medical device regulations, standards (e.g., ISO 13485, FDA CFR 820), and industry guidelines.
5.Deliver training on medical device regulations, standards, and QMS requirements to cross-functional teams.
6.Host and coordinate third-party audits (e.g., ISO certification bodies, notified bodies).
7.Facilitate regulatory agency inspections (e.g., NMPA, FDA, EMA).
Qualifications:
1.Age: 28–42 years
2.Education: Bachelor’s degree or higher in STEM (Science, Technology, Engineering, Mathematics)
3.Knowledge: Proficient in medical device regulations (e.g., China NMPA, EU MDR, FDA QSR) and standards (ISO 13485).
4.Experience: Minimum 3 years in QMS management within medical device manufacturing.
5.Preferred:Experience in building/implementing QMS from scratch.Expertise in R&D process quality management.
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