Main Purpose of Job:
Monitor the compliance to medical device regulations.
Define and implement production / process quality assurance standards for assigned business unit.
Defect analysis and drive continuous improvement with all departments.

Main Responsibilities:
Monitor the GMPs compliance to medical device regulations.
Lead quality assurance activities during new product development (Risk Assessment / Control Plans / Inspection WIs and other necessary documentations).
Ensure production process control methods (including operator self-inspection) are in place and optimize the process improvement methods continuously.
Implement process audit, layered process audit and other necessary quality audits when assigned.
Organize and participate in the root cause analysis and corrective/preventive actions setting up for Top issues and daily batch issues. Keep tracking and verifying the effectiveness of actions for closure.
Manage and monitor NCMR process/status and corrective and preventive actions initiated internal and external and report the progress in a time manner.
Assist to deal with quality complaint from customers.
Manage in process quality control inspectors and final product release in production.

Knowledge, Skills and Experience required:
Min. 5 years work experience in medical device industry, be family with injection moulding process, and ultrasonic welding process is a plus.
Good knowledge in NMPA GMP, ISO13485 and ISO9001. Understanding of IATF16949 is a plus.
Good skills in problem solving and team work needed.
Skills for organization or leadership for quality improvement, experiences of managing QC inspectors.
Good English writing and able to communicate.
Skilled in computer software, MS Word, MS excel, MS PPT.
Positive enterprising with big view of quality contribution to business.