Quality Control Assistance Manager

Responsibility:

• 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.
• To analyze problematic products, coordinate and solve quality problems with relevant.
• Maintain Complaint file and Corrective action & Preventive action system.
• Facilitate communication between functions, multi-facility groups and customers

Qualifications

• 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 Assembly manufacturing.
• Knowledge of FDA Quality System Requirements 21CFR820, 21CFR PART11, ISO 13485, ISO 14971 and Medical Process validation IQOQPQ will be advantageous.
• Knowledge of Master Control, QMS e-documents systems.
• Ability to manage small projects/programs with limited assistance from others
• Certified Internal Auditor
• Ability to use Microsoft Office and email.
• Leadership skills including ability to maintain confidentiality.
• Knowledge and ability to be a consultant of Corrective action & Preventive action program base on 8D methodologies.
• Ability for communication, teamwork and organizational skills to carry out projects to meet timelines.
• Decision making and prioritization skills
• Good English communication, writing and understanding.

Contact : HR

Epic International (Thailand) Co., Ltd.

500/73 Moo 2,T. Tasit, A. Pluakdaeng,Rayong 21140
Tel : 038-010-807 or [081-9275563, 090](tel:081-9275563, 090)-907-5322