PQMS Manager for Goldway
On-siteShenzhen Shenzhen, Guangdong, China
Job Summary
Supervise day-to-day operations of the QMS team, ensuring all quality processes execute efficiently and comply with company policies and regulatory requirements. Manage deployment and maintenance of QMS processes including document control, training, and internal audits, while monitoring performance metrics to identify trends and develop action plans. Prepare for external audits by ensuring documentation availability and responding to findings, and facilitate cross-functional collaboration to resolve quality issues. Manage documentation and resolution of non-conformance reports, conduct risk assessments, and drive continuous improvement initiatives. Guide and mentor the QMS team on performance management and career development. Oversee activities under the NMPA management representative role, including product review, site inspections, product recalls, and post-marketing surveillance. Interact with product development, customer service, and sales to provide direction and consultation.
Required Qualifications
- Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent
- Minimum 5 years of experience with Bachelor's OR Minimum 5 years of experience with Master's in areas such as Quality Management Systems, China management representative of medical devices, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive
- NMPA Management Representative certificate
- Regulatory Requirements
- Quality Management Systems (QMS)
- Project Management
- Data Analysis & Interpretation
- Process Improvements
- Technical Writing
- Budget Management
- Agile Methodology
- Training Content Development
- Regulatory Compliance
- Working in-person at least 3 days per week
- Full-time presence in the company's facilities
Desired Qualifications
- Management Representative for medical devices
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