Quality Engineer
Job ID :
42508BR
Location :
China - Shanghai
:
Job Description
- Monitor and report the performance of products in market by analyzing customer feedback, files of authority, and service report;
- Perform trend analyses through non-conformance monitoring, identify issues, drive to root cause and implement robust corrective actions
- Directly and timely communicate with customer for quality and technical issues;
- Improve efficiency of customer quality feedback system by coordinating between commercial channels and manufacturing forces;
- Plan or participate in validations
- Represent the Quality Department in cross-functional teams and activities such as daily stand up meeting, gemba walk, etc.
- Perform cross-departmental audits include process and product audit
- Review engineering change from product compliance aspect; Manage document control system.
- Understand applicable regulations, guidelines and standards related to product and disseminate Regulatory Affairs communication.
- Follow, interpret and create written Standard Operating Procedures (SOP’s) or Working Instructions
- Conduct trainings on Quality-related items (i.e. GMP, ISO, etc)
- Organize RGA process cross-functionally
Minimum Requirements/Qualifications: (Bullets)
- Major in engineering background with bachelor degree or equivalent
- 5 years above experiences in manufacturing, product development or technical service environment;
- Professional technical or engineering experience; laboratorial instrument industry or multi-technologies know-how will be preference;
- Knowledge and experience on Lean manufacturing
- Strong inter-personal skills;
- Excellent oral and written communication skill in English, be able to work in a multicultural environment;
- Implementation experience in ISO9000 or ISO13485;
- Ability to achieve goals independently within a challenging time frame.
- Project management skill
- Ability to handle conflict with confidence and integrity
Non-Negotiable Hiring Criteria:
- Strong knowledge on data analysis (Pareto Chart, Control Chart) and CAPA
- Major in engineering background with bachelor degree or equivalent
- Ability to achieve goals independently within a challenging time frame.
- Ability to handle conflict with confidence and integrity
- 5 years above experiences in manufacturing, product development or technical service environment;
- Excellent oral and written communication skill in English, be able to work in a multicultural environment
