Responsibilities:
? Liaise closely with project team members to qualify the new sources of the medical device products for the targeted markets;
? Participate in the new supplier pre-evaluation, selection, evaluation & qualification;
? Interface directly with Marketing, R&D, Sourcing, Engineering to establish the quality requirements to the new supplier and the new product;
? Work with the existing / potential supplier to evaluate the quality system compliance and the process capabilities, and on-site audit existing / potential supplier to verify & certify the compliance and the capabilities;
? Follow up the corrective actions to the audit observations with the supplier, and verify the effectiveness;
? Communicate the quality standards / requirements to the suppliers;
? Coach and lead the suppliers to conduct the process validation & verification;
? Provide training capability for Quality team about Quality Management system, product and related standards.

Requirements:
? Minimum College Degree in Science or Engineering discipline;
? Minimum 3-year quality control / quality assurance experience in medical device, pharmaceutical or cGMP related industry;
? Certified ISO 13485 internal auditor
? Resourceful, organized and able to work independently in a fast-paced environment;
? Good communication, interpersonal skills;
? Technically literate, able to assimilate information on multiple product families;
? Must be familiar with AQL sampling inspection plan;
? Knowledgeable of domestic and international quality systems, especially GMP / ISO 13485 / FDA QSR requirements;
? ASQ CQE / Certified Six Sigma Green Belt is preferred; English workable

上班地址：上海