• Implementation and maintaining the Quality Management System and ensure the overall effectiveness of the system involving cross markets level.
• Manage Third Party Logistics (3PL), suppliers and distributors
• Support and conduct audits activities as applicable including external (TFDA / BOH), internal, suppliers and distributor.
• Follow up and coordinate with cross functional team on post auditing activities and drive NC /CAPA activities till closure.
• Track on quality compliance metrics, identify, analyze gap, recommend initiatives for continuous improvement and compliance enforcement.
• Support and coordinate on site management review.
• Support on post market surveillances activities on a timely manner not limited to Field Action, Recall, Medical or Adverse Event reporting.
• Support on document control system and training system.
• Support cross functional product release activities at the regional distribution centers as required including inspection and over labeling/rework.
• Accountable for Quality management of repacking, relabeling, over labeling, kitting, reworking conducted within the DC.
• Support on project assignment/initiatives from the line manager.
• Support/lead activities, projects and initiatives to integrate information from compliance audits and assessments and regulatory trends.
• Identify, escalate regulatory, compliance, and quality issues to management.
• Ensure applicable relevant internal standards and processes across the business without compromising customer expectations.
• Performs other ad hoc related tasks as required.

1.擅長工具
Power BI​

2.其他條件
• Good knowledge of Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) in Taiwan market.
• Preferrable demonstrated knowledge and application of ISO9001, ISO13485 and other international standards.
• Demonstrated knowledge and experience in quality or operations function.
• Knowledge of manufacturing environment or repackaging/relabeling environment
• Familiar with basic quality tools. Ability to execute quality system programs & audits
• Demonstrated ability to handle multiple projects. Proactive team player, able to take charge and follow- through
• Task oriented with proven experience in the delivery high quality work
• Excellent analyzing / decision making / problem solving ability
• Fluency in English language required
• Proficiency in Microsoft Office and other Digital Tools (for example PowerBi)