HireDiversity

Shanghai, CN

Quality Engineer-DCQA--Shanghai-0000081S

Description

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. As a QA Engineer, maintain and improve Franchise Complaint Handling System in JJMS and JJMC
- Understand CV requirements from 1) Corporation; 2) Originating Company; 3) Applicable government/health authority regulations;
- Assist Manager to establish/optimize/implement documented system to meet relevant requirements.
- Alerting manager timely when significant issues are identified.
- Review KPIs monthly and provide initiative & implement improvement action timely.
- Participant internal audit for CV.

2. Complaint handling
- Timely report complaint, gather and send accurate and sufficient information, and samples for complaint cases as per requirement.
- Complaint handling follow-up GOP/SOP/WI of CV on timeframe/relevant requirements meet KPI target and try to get better outcome.
- Review resolution form for imported goods to evaluate logical investigation has completed, discuss with upper management and follow-up originating company if necessary.
- Prepare Monthly CV summary of responsible Franchises per specific format.
- Have a tending analysis for related product in monthly report
- Proactively participant CV knowledge learning via various way - e-net; case study; classroom training; self-learning.
- Carry out complaint handling training to relevant staffs.

3. Fulfill other tasks assigned

4. Comply with EHS & ISO14001

Qualifications


EDUCATION AND EXPERIENCE
- Bachelor degree on pharmaceutical or related subjects.
- 1-2 years experience in quality compliance or related areas in medical device or pharmaceutical industries.

ESSENTIAL SKILLS AND ABILITIES
- Good communication skills and learning ability
- English fluent in reading, writing, oral, listening.
- Familiar with routine operations of computer and software.
- Familiar with routine operations of computer and software.

Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance