Job Description

\xe8\x81\x8c\xe8\xb4\xa3\xe6\x80\xbb\xe7\xbb\x93\xef\xbc\x9a

\xe4\xb8\x93\xe6\xb3\xa8\xe4\xba\x8e\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe8\xb5\x84\xe6\xa0\xbc\xef\xbc\x8c\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe8\xb4\xa8\xe9\x87\x8f\xe7\xae\xa1\xe7\x90\x86\xef\xbc\x8cCAPA\xe5\x92\x8c\xe8\xbf\x87\xe7\xa8\x8b\xe6\xa3\x80\xe6\x9f\xa5

\xe8\x81\x8c\xe8\xb4\xa3\xef\xbc\x9a

• \xe9\xa2\x86\xe5\xaf\xbc\xe6\x96\xb0\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe9\x80\x89\xe6\x8b\x94\xe3\x80\x81\xe9\xa2\x84\xe8\xaf\x84\xe4\xbb\xb7\xe3\x80\x81\xe8\xaf\x84\xe4\xbb\xb7\xe5\x92\x8c\xe8\xb5\x84\xe6\xa0\xbc\xe8\xae\xa4\xe8\xaf\x81\xe7\x9a\x84\xe8\xb4\xa8\xe9\x87\x8f\xe6\xb4\xbb\xe5\x8a\xa8;
• \xe4\xb8\x93\xe6\xb3\xa8\xe4\xba\x8e CAPA\xe3\x80\x81\xe9\xa3\x8e\xe9\x99\xa9\xe7\xbc\x93\xe8\xa7\xa3\xe5\x92\x8c\xe9\xa3\x8e\xe9\x99\xa9\xe8\xaf\x84\xe4\xbc\xb0
• \xe4\xb8\x8e\xe5\x8a\xa0\xe5\xb7\xa5\xe5\x95\x86/\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe5\xaf\x86\xe5\x88\x87\xe5\x90\x88\xe4\xbd\x9c\xef\xbc\x8c\xe9\x80\x9a\xe8\xbf\x87\xe6\x9c\x89\xe6\x95\x88\xe7\x9a\x84\xe8\xbf\x87\xe7\xa8\x8b\xe6\x8e\xa7\xe5\x88\xb6\xe8\xa7\xa3\xe5\x86\xb3\xe4\xba\xa7\xe5\x93\x81\xe8\xb4\xa8\xe9\x87\x8f\xe9\x97\xae\xe9\xa2\x98;\xe4\xb8\x8e\xe7\x8e\xb0\xe6\x9c\x89/\xe6\xbd\x9c\xe5\x9c\xa8\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe5\x90\x88\xe4\xbd\x9c\xef\xbc\x8c\xe8\xaf\x84\xe4\xbc\xb0\xe8\xb4\xa8\xe9\x87\x8f\xe4\xbd\x93\xe7\xb3\xbb\xe5\x90\x88\xe8\xa7\x84\xe6\x80\xa7\xe5\x92\x8c\xe8\xbf\x87\xe7\xa8\x8b\xe8\x83\xbd\xe5\x8a\x9b\xef\xbc\x8c\xe5\xb9\xb6\xe7\x8e\xb0\xe5\x9c\xba\xe5\xae\xa1\xe6\xa0\xb8\xe7\x8e\xb0\xe6\x9c\x89/\xe6\xbd\x9c\xe5\x9c\xa8\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe4\xbb\xa5\xe9\xaa\x8c\xe8\xaf\x81\xe5\x92\x8c\xe8\xae\xa4\xe8\xaf\x81\xe5\x90\x88\xe8\xa7\x84\xe6\x80\xa7\xe5\x92\x8c\xe8\x83\xbd\xe5\x8a\x9b;
• \xe9\xa2\x86\xe5\xaf\xbc/\xe5\x8f\x82\xe4\xb8\x8e\xe5\x85\xb3\xe9\x94\xae\xe8\xb4\xa8\xe9\x87\x8f\xe9\xa1\xb9\xe7\x9b\xae\xef\xbc\x8c\xe4\xb8\xba\xe7\x89\xb9\xe6\xae\x8a\xe8\xb4\xa8\xe9\x87\x8f\xe9\xa1\xb9\xe7\x9b\xae\xe6\x8f\x90\xe4\xbe\x9b\xe6\x94\xaf\xe6\x8c\x81;
• \xe8\xb4\x9f\xe8\xb4\xa3\xe6\x8a\x80\xe6\x9c\xaf\xe5\x86\x99\xe4\xbd\x9c\xe5\x92\x8cSOP\xe5\x92\x8cWI\xe7\x9a\x84\xe5\x88\x9b\xe5\xbb\xba;
• \xe8\xb7\x9f\xe8\xbf\x9b\xe5\xae\xa1\xe8\xae\xa1\xe6\x84\x8f\xe8\xa7\x81\xe7\x9a\x84\xe7\xba\xa0\xe6\xad\xa3/\xe9\xa2\x84\xe9\x98\xb2\xe6\x8e\xaa\xe6\x96\xbd\xe5\xb9\xb6\xe9\xaa\x8c\xe8\xaf\x81\xe6\x9c\x89\xe6\x95\x88\xe6\x80\xa7;
• \xe7\x9b\xb4\xe6\x8e\xa5\xe4\xb8\x8e\xe8\x90\xa5\xe9\x94\x80\xef\xbc\x8c\xe7\xa0\x94\xe5\x8f\x91\xef\xbc\x8c\xe9\x87\x87\xe8\xb4\xad\xef\xbc\x8c\xe5\xb7\xa5\xe7\xa8\x8b\xe5\xaf\xb9\xe6\x8e\xa5\xef\xbc\x8c\xe4\xbb\xa5\xe5\xbb\xba\xe7\xab\x8b\xe5\xaf\xb9\xe6\x96\xb0\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe5\x92\x8c\xe6\x96\xb0\xe4\xba\xa7\xe5\x93\x81\xe7\x9a\x84\xe8\xb4\xa8\xe9\x87\x8f\xe8\xa6\x81\xe6\xb1\x82;
• \xe9\xa2\x86\xe5\xaf\xbc\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe7\x9a\x84\xe8\xb4\xa8\xe9\x87\x8f\xe7\xbb\xa9\xe6\x95\x88\xe5\xae\xa1\xe6\x9f\xa5\xef\xbc\x8c\xe6\x94\xaf\xe6\x8c\x81\xe7\xbb\x8f\xe7\x90\x86\xe7\xbb\x84\xe7\xbb\x87\xe5\x92\x8c\xe7\xbb\xb4\xe6\x8a\xa4\xe4\xbe\x9b\xe5\xba\x94\xe5\x95\x86\xe7\x9b\x91\xe7\x9d\xa3\xe5\xae\xa1\xe6\xa0\xb8/\xe5\xb9\xb4\xe5\xba\xa6\xe5\xae\xa1\xe6\xa0\xb8\xe6\x80\xbb\xe4\xbd\x93\xe8\xae\xa1\xe5\x88\x92;
• \xe6\x94\xaf\xe6\x8c\x81\xe6\x8f\x90\xe9\xab\x98\xe8\xbf\x90\xe8\x90\xa5KPI\xe7\xae\xa1\xe7\x90\x86\xe7\x9a\x84QA\xe6\x9d\xa0\xe6\x9d\x86;
• \xe4\xba\xa4\xe5\x8f\x89\xe6\x94\xaf\xe6\x8c\x81\xe5\x85\xb6\xe4\xbb\x96\xe5\x9b\xa2\xe9\x98\x9f\xe6\x88\x90\xe5\x91\x98\xe7\x9a\x84\xe5\xb7\xa5\xe4\xbd\x9c\xe3\x80\x82

\xe8\xb5\x84\xe6\xa0\xbc\xe5\x92\x8c\xe8\xa6\x81\xe6\xb1\x82\xef\xbc\x9a

• \xe7\xa7\x91\xe5\xad\xa6\xe6\x88\x96\xe5\xb7\xa5\xe7\xa8\x8b\xe5\xad\xa6\xe7\xa7\x91\xe7\x9a\x84\xe6\x9c\x80\xe4\xbd\x8e\xe5\xa4\xa7\xe5\xad\xa6\xe5\xad\xa6\xe4\xbd\x8d
• \xe9\xab\x98\xe7\xba\xa7\xe8\xb4\xa8\xe9\x87\x8f\xe5\xb7\xa5\xe7\xa8\x8b\xe5\xb8\x88--\xe8\x87\xb3\xe5\xb0\x915\xe5\xb9\xb4\xe5\x8c\xbb\xe7\x96\x97\xe5\x99\xa8\xe6\xa2\xb0\xef\xbc\x8c\xe5\x88\xb6\xe8\x8d\xaf\xe6\x88\x96cGMP\xe7\x9b\xb8\xe5\x85\xb3\xe8\xa1\x8c\xe4\xb8\x9a\xe7\x9a\x84\xe8\xb4\xa8\xe9\x87\x8f\xe6\x8e\xa7\xe5\x88\xb6/\xe8\xb4\xa8\xe9\x87\x8f\xe4\xbf\x9d\xe8\xaf\x81\xe7\xbb\x8f\xe9\xaa\x8c
• \xe8\xb4\xa8\xe9\x87\x8f\xe5\xb7\xa5\xe7\xa8\x8b\xe5\xb8\x88--\xe8\x87\xb3\xe5\xb0\x912\xe5\xb9\xb4\xe5\x8c\xbb\xe7\x96\x97\xe5\x99\xa8\xe6\xa2\xb0\xef\xbc\x8c\xe5\x88\xb6\xe8\x8d\xaf\xe6\x88\x96cGMP\xe7\x9b\xb8\xe5\x85\xb3\xe8\xa1\x8c\xe4\xb8\x9a\xe7\x9a\x84\xe8\xb4\xa8\xe9\x87\x8f\xe6\x8e\xa7\xe5\x88\xb6/\xe8\xb4\xa8\xe9\x87\x8f\xe4\xbf\x9d\xe8\xaf\x81\xe7\xbb\x8f\xe9\xaa\x8c
• \xe8\xae\xa4\xe8\xaf\x81ISO13485\xe5\x86\x85\xe9\x83\xa8\xe5\xae\xa1\xe8\xae\xa1\xe5\xb8\x88
• \xe8\xb6\xb3\xe6\x99\xba\xe5\xa4\x9a\xe8\xb0\x8b\xef\xbc\x8c\xe6\x9c\x89\xe6\x9d\xa1\xe7\x90\x86\xef\xbc\x8c\xe8\x83\xbd\xe5\xa4\x9f\xe5\x9c\xa8\xe5\xbf\xab\xe8\x8a\x82\xe5\xa5\x8f\xe7\x9a\x84\xe7\x8e\xaf\xe5\xa2\x83\xe4\xb8\xad\xe7\x8b\xac\xe7\xab\x8b\xe5\xb7\xa5\xe4\xbd\x9c
• \xe8\x89\xaf\xe5\xa5\xbd\xe7\x9a\x84\xe6\xb2\x9f\xe9\x80\x9a\xef\xbc\x8c\xe4\xba\xba\xe9\x99\x85\xe4\xba\xa4\xe5\xbe\x80\xe8\x83\xbd\xe5\x8a\x9b
• \xe5\x85\xb7\xe6\x9c\x89\xe6\x8a\x80\xe6\x9c\xaf\xe7\xb4\xa0\xe5\x85\xbb\xef\xbc\x8c\xe8\x83\xbd\xe5\xa4\x9f\xe5\x90\xb8\xe6\x94\xb6\xe5\xa4\x9a\xe4\xb8\xaa\xe4\xba\xa7\xe5\x93\x81\xe7\xb3\xbb\xe5\x88\x97\xe7\x9a\x84\xe4\xbf\xa1\xe6\x81\xaf
• \xe7\x86\x9f\xe6\x82\x89\xe5\x9b\xbd\xe5\x86\x85\xe5\xa4\x96\xe8\xb4\xa8\xe9\x87\x8f\xe4\xbd\x93\xe7\xb3\xbb\xef\xbc\x8c\xe7\x89\xb9\xe5\x88\xab\xe6\x98\xafGMP/ISO13485/FDA\xe7\x9a\x84QSR\xe8\xa6\x81\xe6\xb1\x82
• ASQ CQE/\xe8\xaf\x81\xe4\xb9\xa6\xe5\x85\xad\xe8\xa5\xbf\xe6\xa0\xbc\xe7\x8e\x9b\xe7\xbb\xbf\xe5\xb8\xa6\xe6\x98\xaf\xe9\xa6\x96\xe9\x80\x89
• \xe9\x9c\x80\xe8\xa6\x81\xe8\x8b\xb1\xe8\xaf\xad\xe6\xb0\xb4\xe5\xb9\xb3\xef\xbc\x8c \xe5\x8c\x85\xe6\x8b\xac\xe5\x8f\xa3\xe8\xaf\xad\xe5\x92\x8c\xe4\xb9\xa6\xe9\x9d\xa2\xe4\xba\xa4\xe6\xb5\x81

Summary:

Focus on supplier qualification, supplier quality management, CAPA and process check

Duties & Responsibilities:

• Lead the quality activity in the selection, pre-evaluation, evaluation and qualification of new supplier;
• Focus on CAPA, risk mitigation and risk assessment
• Work closely with processors / suppliers to resolve product quality issue through effective process control; 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;
• Lead / participate in critical to quality projects and provide supports to special quality projects;
• In charge of technical writing and the creation of SOP and WI;
• Follow up the corrective/preventative actions to the audit observation and verify the effectiveness;
• Interface directly with Marketing, R&D, Sourcing, Engineering to establish the quality requirements to the new supplier and the new product;
• Lead supplier\xe2\x80\x99s quality performance review, support manager to well organize and maintain supplier surveillance audit/ annual audit master plan;
• Support to improve QA leverage on operation KPI management;
• Cross supports for the work of other team members.

Qualifications & Requirements:

• Minimum College Degree in Science or Engineering discipline
• Senior QE--Minimum 5-year quality control/quality assurance experience in medical device, pharmaceutical or cGMP related industry
• QE--Minimum 2-year quality control/quality assurance experience in medical device, pharmaceutical or cGMP related industry
• Certified ISO13485 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
• Knowledgeable of domestic and international quality systems, especially GMP/ISO13485/FDA QSR requirements
• ASQ CQE/Certificate Six Sigma Green Belt is preferred
• English proficiency required, especially in oral and written communication

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click

Cardinal Health