รับสมัคร RA/QA Officer

NIPRO SALES (THAILAND) COMPANY LIMITED

หมวดหมู่ งานพัฒนาองค์กร/ISO

จำนวนที่รับ 1 อัตรา

ลักษณะงาน

1. Support any Quality Regulatory Compliance related special projects that assigned bycompany policy as well as by the change of Thai FDA regulation and requirement. 2. Prepare, register, and gather documents related to registration process to get both new and renew import licenses e.g. Certificate of Free Sale/ Certificate of Goods/Free Sale Certificate, ISO/ any other applicable standard certificate, product catalog/brochure, Instruction for use/ Notice, and declaration letter (if needed). 3. Incorporate with QA/RA manager to oversee the changes and/ or new legislations, requirements, applicable standard and/ or requirement that lead to impact to registration process and Quality Management System. 4. Gather, file, and maintain all data/ information regarding FSCA/ AE/ Customer Complaint and any other related QA/RA issues. 5. Act as Document Control Center to handling all quality and regulatory documents related to applicable standard for Quality Management System.

คุณสมบัติผู้สมัคร

1. bachelor’s degree in science, Medical or related fields. 2. 1-3 years of experience in Medical Device products registration process or related field. 3. Knowledge of registration process and/ or DCC for any applicable QMS (ISO13485). 4. Good command in English & Thai both written and spoken. 5. Good computer literacy (MS Office: Word, Excel, Access, and Power Point).

เงินเดือน/ค่าตอบแทน

- ตามความสามารถผู้สมัคร

สวัสดิการ

จำนวนวันและเวลาทำงาน

5 วัน/สัปดาห์