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Introduction:

Medical Device

Responsibilities:

• Manage the production operation, make sure production process strictly compliance with all company policies.
• Review production order and plan, manage production to make sure produce qualified products within plan.
• Review production report, lead team to analyze the variance and take effective actions.
• Push PE to conduct equipment management and maintenance, offer technical support to production to make sure achieve production plan.
• Promote lean and Kaizen, utilize VSM, cell line and other lean tools to optimize process to improve efficiency and scrap, eliminate waste, effectively control labor hours.
• Monitor quality checks and solve quality issues in production, ensure production process comply with ISO13485/ISO9001/FDA regulations.
• Responsible for labor management and maintain work environment, push and lead 5S and EHS activities of production department.
• Train and motivate production team, ensure the work completed on time. Manage production workers skill training to make sure them qualified before on job.
• Participate management review, communicate and coordinate with other departments.
• Deal with other assignments assigned by superior. 

Requirements:

Above 5 years relative work experience.

Strong analytical skills, solutions-and process orientated, organized and structured.

Continuous improvement focused, self -directed and result orientated.

Proficient in Failure & Root Cause analysis and corrective action deployment.

Knowledge of Lean manufacturing and 6 sigma is preferred.

Excellent communication, production management.

Medical device standard and regulation, ISO 13485, FDA 21CFR and cGMP, preferred.