【外商醫療器材】Commercial Quality Specialist_50-65K保障13個月，英文精通_115PC
- Jhongshan, Taipei City
- $50,000-65,000 per month
- Permanent
- Full-time
- 職務編號: 6181
- 更新日期: 2025-07-01 17:01:36
- 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.