Senior QA Specialist

Job description

JOB DESCRIPTION:

Major Responsibilities :

·  Maintain quality management system in compliance with China GSP (Good Supply Practices for medical devices), Manufacturer and Marketing Authorization Holder (MAH) to ensure compliance, effectiveness, outgoing product quality and continual improvement.
·  Ensure quality training are appropriately assigned, and implemented within target timeline, training records maintenance and follow up.
·  Interaction with the customer service and the vigilance group with regards to potential reportable events, medical events, and field actions.  Responsible for reporting Field Actions, recalls and Medical Events to authorized agency.
·  Supplier management of qualification and monitoring.
·  Distributor management of qualification and monitoring.
·  Implementation of affiliate related divisional quality procedures and local procedures. Create / revise local procedures as required.
·  Qualification review for the first sale of medical devices.
·  Support internal and external audit, and CAPA follow up. Primary contact for external auditors and government inspectors on-site.
·  Product return confirmation for logistic team when necessary.
·  Quality issues follow up (Quality Hold/Stop Ship/Field Action), work closely with warehouse for any quality actions, including but not limited to relabeling, rework etc.
·  Customer Complaint escalation and communication with global
·  Ensure compliance of contracted warehouses and distributors with China & Hong Kong regulations and Abbott policies and procedures.
·  Monitor medical device destruction.
·  Other quality related works as required.

Minimum Education Required :

Bachelor’s degree

Minimum Experience Required:

·  At least 3 years of working experience in medical device quality management
·  Familiar with medical device regulation including but not limited to China GSP
·  Familiar with NMPA system, including but not limited to AE/Recall reporting process and system.
·  Experience of working within a global, multi-cultural, matrix organization
·  ISO13485 internal audit qualification is preferred.
·  Common English Level 6 or above, good in spoken and written.
·  Proficient in Microsoft office applications.
·  Diligent, patient, hard working with high sense of responsibility.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

China > Shanghai : 388 W. Nanjing Road, Ciros Plaza

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable