Company Background:

• A leading American company.

Key Responsibility:

• China Quality management systems setup, update and maintenance. Also support Taiwan QA on QMS setup.

• Generation of CAPA, Deviations and NC reports where appropriate, and assist management with review and approval of corrective and preventative action.

• 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.

• Document Control, administration of Document Change Orders.

• Coordinate Electronic QMS (Agile) implementation including: documentation requirements, loading scanning documents and helping engineering team on agile projects.

• Interface with customers, vendors and/or government apartment when appropriate to confer on specific quality issues.

• Review and approve product adverting, marketing materials, promotion items etc., support Marketing on online and outdoor promotion activities.

• Cooperation with Marketing and global team on designing, approval packaging and SP.

• Manager any quality related issues, feedback to manufacturing site and get solution.

• Manager QARA Assistant on daily work.

• Performs other assignments related to the QA department as directed by Sr. RAQA Manager GC.

Key Qualification:

• 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.

• Detail oriented and organized; good knowledge on ISO13485, familiar with China MD regulations.

• Fluent in Mandarin and English, computer literate.