职位描述：
responsibilities:
- establish and maintain document control process, including origin of internal or external, to ensure only valid and current version can be used;
- maintain all quality related records well controlled to ensure a good record practice is implemented through routine training and monitoring in on-line document system;
- support to monitor and follow up the capa status and support on internal audit program to ensure the system is consistently complying to applicable standards/regulations;
-responsible for quality system data collection and analysis to detect any abnormal trending or opportunity for improvement
- responsible to support product registration per request
- other responsibility defined in related company procedures or assigned by qara supervisor
qualifications:
-bachelor’s degree or above
-iso13485:2016 internal auditor certificate
-3-year above similar quality system management experience in medical device or pharmaceutical industry
-solid understanding on iso13485; and familiar with gmp&gsp or other medical device related regulations
-good capa management ability
-good command of english and mandarin
-good knowledge with pc application
-on-line document control system experience
-accountability, learning agile, “can do” attitude, teamwork spirit
-down to earth capability
-qara team at both corporate and regional levels as well as the functional departments in shanghai