Senior Quality System Engineer
About this position
The Senior Quality System Engineer is responsible for ensuring compliance with regulations and standards, as well as facilitating communication between different departments.
Responsibilities
• Interfaces all organizations in plant to review policies and procedures, regulations, and work instructions
• Participates in internal, external, customer, supplier audits and regulatory inspections
• Review and monitor new or updated QMS and relevant regulation to ensure the compliance of company system
• Maintain audit programs and Management review and provide reporting results to management
• Maintain and supervise for Complaint file, Corrective action & Preventive action system and Risk Management (ISO14971)
• Facilitate communication between functions and multi-facility groups
Requirements
• Bachelor degree or higher in Engineering field or equivalent industry experience
• A minimum of 10 years of experience in the Quality System Management
• Experienced in the position of QMR is advantage
• Certified Internal Auditor
• Knowledge of U.S. FDA inspection, Quality System Regulation 21CFR820, 21CRF PART11, MDD/MDR, ISO 13485, ISO 14971, DMR, DHR, Process Validation IQOQPQ, GMP and GDP are beneficial
Benefits
34,000 - 59,000 THB per month