Quality Assurance AM-FMCG
Consultant Lavency Zhu
Date posted 30 September 20192019-09-30 2019-11-29 fmcg 上海市 CN CNY 250000 330000 330000 YEAR Robert Walters https://www.robertwalters.cn https://www.robertwalters.cn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
Under general direction from the Sr. RAQA Manager Greater China, the Assistant QA Manager will be responsible for managing QA activities for China, along with providing support to the Sr. RAQA Manager on daily administration events. Support commercial team on good services as requested by customer, handle any product quality related issues and/or needs. Work with Marketing on Adverting and packaging requirements.
1. China Quality management systems setup, update and maintenance. Also support Taiwan QA on QMS setup.
2. Generation of CAPA, Deviations and NC reports where appropriate, and assist management with review and approval of corrective and preventative action.
3. Ability to interpret and apply regulatory and quality requirements.
4. Auditing and Compliance:
1. Ensures performing internal audits to regulatory compliance in all areas by assessing compliance to standards and to the internal Quality System, including investigation, presentation of observations and findings and reporting.
5. Document Control:
1. Administration of Document Change Orders
2. Coordinate Electronic QMS (Agile) implementation including: documentation requirements, loading scanning documents and helping engineering team on agile projects
3. Administration of controlled documents e.g. SOP’s and the like, and ensure SOP requirements are met.
6. Customer and Supplier Management:
7. Interface with customers, vendors and/or government apartment when appropriate to confer on specific quality issues.
8. Interface with CFDA on audits and product inspections.
9. Participate and/or review vendor and 3rd party audits as deemed necessary in the quality plan.
10. Review and approve product adverting, marketing materials, promotion items etc., support Marketing on online and outdoor promotion activities.
11. Cooperation with Marketing and global team on designing, approval packaging and SP
12. Manager RAQA team meetings and trainings.
13. Manager any quality related issues, feedback to manufacturing site and get solution.
14. Good service to customers for any needs on RAQA parts.
15. Manager QARA Assistant on daily work
16. Performs other assignments related to the QA department as directed by Sr. RAQA Manager GC.
• Proficient knowledge of Quality Assurance techniques and methodologies.
• Complies with all company policies and procedures.
• Conducts self in a professional manner with customers, coworkers and management.
• Ability to communicate effectively in both written and oral form with all levels of management.
• Good knowledge on ISO13485, familiar with China MD regulations.
• Detail oriented and organized.
• Fluent in Mandarin and English.
• Computer literate
• > 5 years’ experience in Quality Assurance discipline.
• Bachelor’s Degree
About the Company:
It is one of the world leading medical device company from US.