Job Description

Under general direction from the QA Manager, the position is responsible for regulatory compliance and quality assurance of CooperVision China covering the QMS and PMS modules, in accordance with NMPA regulatory and quality requirements and CooperVision internal procedures.

• Ensure an efficient and effective Quality Management System is developed and maintained in line with business needs and regulatory and quality requirements.
• Evaluate and report the performance of QMS implementation and 3PL daily operations, define necessary actions for continuous improvement from time to time.
• Perform internal audit and 3PL audit on annual basis.
• Identify potential regulatory compliance risks based on changes in regulations/standards, country specific matters or other unique characteristics. Manage the communication and escalation pathway in a consistent manner and play a key role in mitigation activities.
• Directly interface with customers/consumers for critical quality and compliance queries/issues resolving, manage authority inspections and annual reports.
• Ensure the smooth and compliant daily operations including complaint handling, AE management, PMS cases resolving, PRER reporting & filling, Medical Device Vigilance etc.
• Conduct QMS/regulation trainings to CooperVision China staff to continuously promote quality and compliance awareness.
• Promote and implement regulatory requirements pertaining to computer systems.
• Responsible for changes / renewals of the company’s medical device operating license application.
• Any other tasks and/or special projects (e.g. UDI) as assigned.

Knowledge, Skills and Abilities:

• Proficient knowledge of ISO 13485 and China medical device regulations and quality assurance techniques and methodologies
• Ability to understand product knowledge and basic technical materials
• Be able to manage multiple tasks and perform with accuracy and a high attention to details
• Excellent communication and interpersonal skills with internal and external stakeholders
• Proficient in reading, writing, listening and speaking in English
• Team management experience is a plus

Work Environment:

• General office environment
• Flexible hours to support the international nature of the job

Experience:

• > 5 years regulatory compliance and quality assurance experience in medical device industry
• Direct experience in Quality Management System management and/or 3PL monitoring is a must.
• Direct experience in PMS module is a plus

Education:

• Bachelor degree in related Majors (e.g. biological/chemical/pharmaceutical/material/etc.)
• ISO: 13485 internal auditor certified