QA Manager--某听力技术(上海)有限公司

Purpose of the Job
Play as the leading role to continuously improve the Quality Management System (QMS) and ensure the effective implementation of QMS. Maintain the effectiveness of Medical Device Production License, Medical Device Sales License and ISO 13485/9001 certificates
Monitor QMS related regulations/standards to ensure the compliance in time.
Apply / update Medical Device Production License and Medical Device Sales Licenses as business needs
Lead the company to pass the certification audit and annual surveillance audit of ISO 13485 / 9001 certificate;
Take lead in passing the QMS audit for new product homologation , extended / change product homologation and any announced or unannounced authority inspection;
Organize the internal audit, external audit and management review meeting. Coordinate the appropriate follow-up actions for the findings from the audits and management review;
Take charge of documents control involving collecting and releasing for all QMS documents;
CAPA follow-up ;
Monitor and handle the adverse events according to China Medical Device regulation an global policy;
Act as the main role for duly responding to the post-market surveillance;
Proofread the User Guide and Label to ensure the compliance of the regulation;
Collect the data relating to medical device production and sales required by government and submit in a timely manner;
Performs other duties as required by Manager;

Bachelor or above, Engineering, Electronics, Biology, Pharmacy, Medical Science relevant professional.
 At least 5 years working experience in MDD quality system.
- Comprehensive knowledge in Medical Device Regulation and relevant National / Industrial standards.
- Proven experience in FDA’s inspection as well as ISO 9001 & ISO 13485 certification/surveillance audit.
 Strong willingness of team work
- Careful and high responsibility
- flexibility
- Ability to work under pressure,stress resistance
Good English communication skill in reading, speaking and writing
Microsoft Office