天津招聘

RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES:

(1)   Organize and establish the quality management system integration into EMEA BMS to ISO 9001 & ISO 13485 requirements as appropriate and CFDA requirements for China, job responsibilities and job operation rules, guiding and supervising the implementation of the system, and inspect the implementation status, find problems in a timely manner to correct and continuous improvement.

(2)   Responsible for product quality inspections in China and Malaysia.

(3)   Responsible for the effective integration and maintenance of ISO 9001 & ISO 13485 and CFDA quality management system, implement corrective and preventive actions and continuous improvement actions for China, Singapore and Korea.

(4)   Responsible for the quality management system and quality control training, internal and external audits management review, document control etc. for China, Singapore and Korea

(5)   Responsible for unqualified medical device confirmation, Effective supervision and documentation over the handling of nonconforming product.

(6)   Responsible for the investigation, processing and reporting of medical device & PPE products quality complaints and quality accidents.

(7)   Organizing and guiding collection and reporting of medical device adverse events.

(8)   Responsible for the management of medical device recalls within the region.

(9)   Provide technical support to commercial team including but not limited to test reports, technical documentation, CoA, CoC.

(A)  Medical Device (MED, SU, GBUs)

(1)   Complaint Management

Support customer complaint handling.

Input customer complaints to TrackWise.

Importer's Quality assurance documents creation/ maintenance.

(2)   CFDA , HSA and relevant agencies QA requirement compliance

Regularly update Product standards

Assist in establishing China & SEA internal SOP and maintenance.

Assist in reporting and monitoring Adverse effect case to CFDA if happens.

(3)   Training

Attend relevant seminars as much as possible.

(4)   Importation and Logistics

Communication with warehouse on QA matters as necessary.

(B)  PPE (IND, SU GBUs)

(1)   Customer Complaint handling

Input Customer complaints to TrackWise

Be involved in complaint verification process

Send the feedback letter to customer

KEY POSITION REQUIREMENTS

Education

• Bachelor’s Degree in a relevant scientific field e.g. pharmacy, chemistry, medical technology, biotechnology, etc.

Job Experience

• Minimum 3 years in Regulatory Affairs and Quality management in medical device import Business Company, specifically related to medical devices and Industrial and PPE.

Knowledge and Skills

• Understanding of local regulations as applicable to business
• Knowledge of China medical device and PPE regulatory systems
• Understanding of products standards
• Exposure to Quality methodology, including QA / QC / SPC techniques
• Detailed knowledge and understanding of ISO systems (9001, 13485)
• Knowledge of effective auditing techniques and practices
• Strong PC literacy, sound understanding of Microsoft Office suite

Desirable Job Competencies

• Collaboration and teamwork when working with key partners
• Team player
• Results Oriented
• Good communication and interpersonal skills

上海外服（集团）有限公司隶属于上海东浩兰生国际服务贸易(集团)有限公司，为国内领先的人力资源服务企业。上海外服在人才招聘与推荐方面有着30多年丰富的专业经验，每年为外商投资等企业推荐约40000余名各类人才，涉及计算机、电子、通讯、机械、自动化、化工、物流、建筑、纺织服装、快速消费品等众多行业。迄今为止，已向8000余家外企提供了数十万名专业人才。