Job Summary
To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily.
The requirements listed below are representative of the knowledge, skills, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Perform quality inspection, assurance of products on site
Essential Job Duties and Responsibilities
*Perform Supplier quality checks (in-process or outgoing) Ensure Supplier process quality meets the specifications and requirements stipulated in the work instructions or procedures
*Conduct full inspection on first article samples and documentation
*Perform start-up and verification of part performance to specification of all products Perform suppliers’ quality management system audit and reporting *Perform sample inspection on components, products and materials as per specification
*Perform in-depth investigation of claims and quality issues, define and implement CAPA, complete documentation of results
*Provide recommendation for quality improvement and enhancement on products whenever necessary
*Record inspection results in inspection report and maintain proper documentation
* Working in 江浙 areas
Required Experience
* 5 years experience in Quality Control and Assurance
*Candidates with more experience will be considered as Senior Quality engineer *Degree in Engineering or equivalent Knowledge of FMEA, SPC, Gage R&R, CPK study, SCAR, and Quality Control Plans necessary Knowledge of ISO 9001/13485
*Ability to function in a team environment Strong interpersonal and communication skills
*Must be an energetic self-starter, focused on completing tasks without close supervision
*Excellent computer knowledge using Microsoft Office Suite
*Fluency in English and Mandarin
Preferred Experience
• Experience working with FDA regulated medical devices