Senior Quality Management System

Major Responsibilities:
- Quality Management System (QMS), Environment management system (EMS)
• Develop, maintain and improve QMS, EMS includes set up the standard operation procedure, work instruction and its operation processes complies to the QMS standards (ISO9001, AS9100, ISO13485), EMS standards (ISO14001).
• Coordinate the related functions to set up QMS and EMS objectives, action plan and lead the implementation to support the organization’s goals.
• Enhance QMS, EMS conformity, effectiveness thru the monitoring and measuring its operations and continuous improvement initiative. Report, handle and monitor the system nonconformity to ensure the corrective and preventive action taking effectively.
• Organize and lead the internal quality audit programs to monitor and measure the conformity and effectiveness of the QMS, EMS. Initiate necessary continuous improvement activities including root cause corrective action and preventive action.
• Reporting to Top Management on the performance of the QMS, EMS, any need for improvement and leading the activity to fulfill the improvement needs.
• Leading ISO Audits, Customer Audits and FDA audit
- Continual Improvement
• Review company’s processes, identify cost savings opportunities, and implement significant yearly cost reduction. Lead multiple cross-functional Six Sigma & Lean projects to support continuous improvement activities. Provide training in Six Sigma, Lean Mfg and Root Cause and Corrective action methodologies.

Special Requirements for this position:
• To assure the QMS & EMS system is implemented under controlled condition; always work toward high quality.

Minimum Qualification Requirements:
- Bachelor’s degree in a technical field.
- Ability to create unity, succeed and grow in a fast paced environment, Quality System.
- Dynamic, high energy, multitasking, high initiative, creative, innovative thinker, driven. Self-directed, be able to take initiative with minimal guidance.
- Strong leadership and team building skills with proven ability to build relationships and gain credibility to effectively lead cross-functional teams.
- Excellent organizational, analytical, problem solving, facilitation, verbal and written communication skills to all levels of the organization.
- 5 years plus of progressive experience in operating the Quality Management system or (and) Environment Management system.
- Lead Auditor of ISO14001, ISO9001, AS 9100 or ISO13485 is prefer.
- Experience in FDA compliance is prefer.

- Health Care
- Training Development
- International travel

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