Quality Management System Officer
Urgo Healthcare Products Co.,LtdSupervisor : QMS Supervisor
Subordinate : -
Responsibility and Authority :
Responsibility:
Complaint handling
Register all of complaint and feedback to customer.
Organizing the investigation process to find out the root cause and proposal for CAPA.
Issue the complaint investigation report and submit to customer.
Follow up the correction and corrective once the target is reach.
Cooperate with QC if there is required to block stock and issue NCP due to the risk of product quality.
Closing the complaint report.
Update risk management file for any impacting for complaint action.
Supporting of product and process deviation's corrective action and preventive action (CAPA) for process improvement and reduce non-quality cost.
Filling the complaint report.
Internal CAPA follow up
Register all of NCR, CA and observation.
Submit the NCR, CA and observation to perform investigation and CAPA feedback by auditee.
Follow up the correction and corrective action once the target date is reach.
Closing the CAPA report.
Filling the NCR, CA and observation report.
Change control
Register and update control log of change control for status of each number.
Inform project leader and team for progress of each change control once document / record are approved; green light, cancel, closing.
3. l. 17. Updating of monthly report for change control to all project leader, supervisor, and manager team.
Authority
Deciding what correction from complaint investigation should be carried out for non-conforming products.
- Education : Bachelor degree of Science (Microbiology, Biology or related filed)
- Computer skills (MS Word, Excel, Power point, Internet, and others)
- Good command of English (Reading, writing, and speaking).
- Good communication for listening, speaking, and writing skill.
- Understanding requirement of ISO standard, GMP, or other standard / regulation for medical device and can provide or prepare the related document.
- Have knowledge of Quality Control and Statistical Techniques.
- Have knowledge of investigation techniques and CAPA handling.
- Have knowledge of product solving.
- Have product and process knowledge.
- Provident Fund
- Staff training and development
- Fuel/transportation fees
- Marriage gift
- Ordination gift
- 5-day work week
- Social security
- Health insurance
- Accident Insurance
- Ordination leave
- Employee's uniform
- Funeral payment support
- Annual trip or party
- Annual bonus