Quality Engineer

Job Description

Job Description

Job Title: Quality Engineer

Reports To: Quality Manager

Group/Division: China Operation

Career Band: Band IV-VI

Job Track: Professional

Position Location: CMC factory, Guangzhou, PRC

Number of Direct Reports: 0

Day/Shift (if applicable): Day

FLSA Status (Exempt/Non-Exempt): N/A

Position Summary: (1-2 sentences)

The Site Quality Engineer is primarily responsible for the overall quality satisfaction of the customer base, for ensuring establishment of processes that consistently deliver best-in-class quality and for instilling quality awareness in the cross functional team(s). The role includes the assessment of quality, reliability and satisfaction levels; driving cross functional and cross organizational teams to improve quality; failure analysis; design of experiments; interaction with engineering, manufacturing, NPT teams, contract manufacturing partner(s), customers and the business units utilizing structured problem solving tools and techniques and the completion of tasks and objectives that support quality improvement.

• Monitor and report the performance of products in market by analyzing customer feedback, files of authority, and service report;
• Handle customer complaint and failure replacement;
• Improve efficiency of customer quality feedback system by coordinating between commercial channels and manufacturing forces;
• Organize RGA process cross-functionally; support localized product registration (MFG site);

• Conduct process audit and product audit to identify improvement opportunity; analyze root cause for quality problem and work through corrective and preventive action;
• Routing follow up product quality issues;

• Review engineering change from product compliance aspect;

• Manage document control system.

• Major in Industrial, Engineering related background.
• 3 years above experiences in instrument Quality management aspect, medical device quality related experience is preferred.
• Excellent oral and written communication skill in English, be able to work in a multicultural environment.
• Strong inter-personal skills.
• Implementation experience in ISO9000, ISO13485 knowledge is preferred. ISO9000 and ISO13485 internal auditor is preferred.
• Familiar with medical device GMP requirements is preferred.
• Ability to achieve goals independently within a challenging time frame.
• Professional technical or engineering experience; laboratorial instrument industry or multi-technologies know-how will be preference.
• Knowledge and experience on Lean manufacturing is preferred.
• 6 Sigma knowledge is preferred.
• Can comply with the arrangement of company for transferring to other city temporary(in recent 2 years).