Senior Quality Engineer
About this position
Senior Quality Engineer position with responsibilities in ensuring compliance, maintaining audit programs, and facilitating communication.
Responsibilities
• Reviews regulatory, QMS and customer requirements to ensure compliance and meet the requirements.
• Ensure the quality of product and process to meet with the regulation and customer’s requirement.
• Maintain audit programs and Management review and provide reporting results to management.
• Participates in internal, external, customer audits ( and regulatory inspections).
• Maintain Complaint file and Corrective action & Preventive action system.
• Maintain Process Validation activities.
Requirements
• Bachelor degree or higher in Engineering field or equivalent industry experience.
• A minimum of 10 years of experience in the Quality function.
• Experience for both of Quality Assurance engineer (In process/product and customer quality) and Quality Management System in electronics manufacturing.
• Experience in PCBA or complete medical device will be advantageous.
• Knowledge of FDA Quality System Requirements 21CFR820, 21CFR PART11, ISO 13485, ISO 14971 and Medical Process validation IQOQPQ will be advantageous.
Benefits
29,000 - 45,000 THB per month