Head of Quality Assurance
This is an excellent opportunity for candidates who wish to join an aggressive growing global Contract Logistics Company with a strong network within Asia. The company is continuously investing in Asia and is currently serving worlds top MNCs operating in APAC
1. To enhance the company
in the field of medical equipment and pharmaceutical logistics qualifications
and ability to maintain and expand the relevant business to provide quality
management of professional support;
2. To guide and cooperate with the relevant departments to prepare and meet from all sides of the inspection and audit, Correct and close the discovery item.
1. Responsible for the maintenance and renewal of the medical equipment business license of Shanghai Branch; Responsible for guiding the necessary branch to prepare and apply for medical device business license.
2. Responsible for guiding
the necessary branch preparation and through GSP certification, third party
drug logistics storage and distribution business applications.
3.Participate in the creation and improvement of ISO13485 system, ISO13485 certificate acquisition and maintenance
4.Responsible for the preparation and review of medical equipment and drug related quality system documents, and is responsible for supervising the implementation.
5. Participate in the
Shanghai branch to meet the government departments from the flight inspection
and customer audit, to guide the non-compliance correction and closure
6. Responsible for the collection of medical equipment and pharmaceutical business-related laws, regulations, regulations and other relevant provisions, the implementation of dynamic management, and the establishment of archives and catalog list
7. Responsible for the
first audit, at the same time to participate in the timely collection, update
the operation of medical equipment and pharmaceutical quality information, the
establishment of the product quality files and directory list
8. To guide the confirmation of nonconforming products and to monitor the implementation of nonconforming product handling processes.
9. Responsible for the
investigation, handling and reporting of quality complaints and quality
accidents related to the operation of medical devices and medicines; and the
collection and reporting of adverse events.
10. Responsible for supervising the branch to verify, calibrate and improve the equipment and equipment related to medical equipment and pharmaceutical logistics.
11. Responsible for providing training, guidance and review of medical equipment and drug quality management to subsidiaries, contractors and other related parties, including but not limited to storage, acceptance, storage and distributio
1. Experience with more
than 5 years in quality management of medical devices and pharmaceuticals,
including at least 2 years experience in management of medical devices and
2. Has a comprehensive and profound understanding and grasp of medical equipment, drug quality management laws and regulations and ISO13485 system in Shanghai
3.The QA head needs to well verse in ISO 13485 & ISO 90001 and over. He or she will be responsible for all quality issue within the company
4. Have experience setting up QMS structure to enhance the current system and process and to provide guidance to the DCs (13485 + ISO90001)
5. Possess good relationship with FDA is a must.
6. Over 15 years of QA experience