Job ID :
China - Shanghai
- Establish and maintain supplier & dealer quality process and procedures to meet company policies and regulatory requirements.
- Be responsible for evaluating and improving suppliers’ quality system, including contract manufacturer, OEM suppliers, service suppliers and indirect material (non-BOM) suppliers.
- Be responsible for evaluating and improving dealers’ quality system, lead assessing and implementing on local quality regulations and facilitate necessary improvement projects to enhance compliance and efficiency of dealer quality management.
- Be responsible for maintaining supplier & dealer annual audit plan, conducting and overseeing audits execution as well as finding and supplier & dealer CAPA closure.
- Be responsible for establishing, collecting, trending and reporting supplier & dealer quality metrics (audit findings, CAPA, etc).
- Support to perform risk classification, selection, evaluation and qualification of suppliers per purchasing control requirements and oversee their placement on the approved supplier list (ASL).
- Support OEM projects for supplier and product qualification to meet medical device standards, relevant procedures and regulatory, including audit.
- Develop and deliver training to internal teams and suppliers & dealers on purchasing controls and dealer quality management processes, influence and enhance organization’s quality & compliance awareness for supplier & dealer management.
- Lead global quality initiatives and closely monitor the completion for both supplier and dealer quality management.
- Be fully engaged in internal & external audits for supplier & dealer quality management processes.
- Establish supplier and dealer’s quality agreements.
- Other tasks assigned by line manager.