PQMS Manager
Core
Oversees Quality Management System (QMS) operations, regulatory compliance (NMPA), and product quality for medical devices.
Role type
Senior Quality Management System Manager
Builds
Compliant medical device operations and quality processes
Domain
Medical Devices / Highly Regulated Industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems, Regulatory Compliance, Risk Assessment, Non-Conformance Report Management, Audit Preparation, Cross-Functional Collaboration, Process Improvement, Team Mentoring, Technical Writing, Budget Management
Preferred skills
NMPA Management Representative Certification, Medical Device Management Representative Experience, Project Management, Data Analysis, Agile Methodology, Training Content Development
Technologies
N/A
Responsibilities
Supervise QMS team operations and ensure compliance with company policies and regulatory requirements; Manage deployment and maintenance of QMS processes including document control, training, and internal audits; Monitor QMS effectiveness by analyzing performance metrics and developing action plans; Prepare for and support external audits and inspections; Facilitate cross-functional collaboration to resolve quality-related issues; Manage documentation and resolution of non-conformance reports; Conduct risk assessments and manage risk mitigation activities; Drive continuous improvement initiatives within the QMS; Guide and mentor the QMS team regarding performance and career development; Oversee NMPA management representative activities including product review, inspections, recalls, and post-marketing surveillance; Interact with product development, customer services, and sales/marketing to provide direction and consultation.
Seniority
Senior, hands-on IC with management responsibilities