SSMR AT Process Engineer 工艺工程师

1.New Products Introduction

2.Production process set up, verification, validation, optimization

3.Production documentation creation

4.Production / Installation technical support and troubleshooting

5.SCM related Nonconformity follow up and problem solving

6.Support internal & external audit

7,Other Process engineering activities defined in SOPs

Qualifications and experiences:

-Have more than 5 years of work experience in the process engineering of Class III medical devices

-Be familiar with medical device regulatory standards such as FDA QSR, ISO 13485, GB/T 42061, etc.,

-Be able to integrate regulatory requirements into the process design and production process to ensure product compliance.