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บริษัท ออโธพีเซีย จำกัด

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Apr 4, 2025

ผู้แทนฝ่ายบริหารระบบบริหารคุณภาพ (QMR)

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Mueang Chachoengsao, Chachoengsao

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number of positions icon1 อัตรา
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Job Descriptions
Quality Management System (QMS): 1. Develop, implement, monitor, and maintain quality Management system to meet applicable standards (e.g., ISO 13485, ISO 17025, ISO 14971, GMP, Thai FDA and US FDA Regulations). 2. Promote quality awareness, implement, and enforce the company's QMS and regulatory requirements for the improvement of current processes, controls, and quality systems. 3. Manage and lead internal and external audits. 4. Drive process owners to take corrective actions to resolve problems. 5. Control and update document including quality record in accordance with system requirements. 6. Follow up on KPI Results and report to management including suggestions. 7. Establish management review meetings. 8. Process renewal and license updates in timely manner. Quality Assurance (QA): 1. Manage NC and CAPA (investigations, root cause determination, implementation, and effectiveness) to ensure they are adequately documented and addressed while ensuring timely completion of all NC and CAPA activities. 2. Prepare and implement product and process risk management plans. 3. Prepare and execute validation processes. 4. Train and motivate employees to ensure quality standards are met. 5. Maintain recall program and coordinate mock recalls. 6. Manage and coordinate customer claims.
Qualifications
  1. Bachelor's degree in science, engineering, or a related field.
  2. At least 5 years of experience in quality system functions or related fields would be an advantage.
  3. Experience in the medical device industry is preferred.
  4. Knowledge of GMP, ISO 13485, ISO 17025, Thai FDA, and US FDA requirements is an advantage.
  5. Certified Internal Auditor.
  6. Possess a quality mindset, strong motivation, logical thinking, problem-solving, and management skills.
  7. Good command of English.
BenefitsSee all Benefits.
How to apply
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    Contacts
    ฝ่ายทรัพยากรบุคคล
    บริษัท ออโธพีเซีย จำกัด
    32/6 หมู่ 11
    Khlong Preng Mueang Chachoengsao Chachoengsao 24000
    Tel. : 033-599-412 , 063-363-1333
    Email : orthope_147@trustmail.jobthai.com (Email for job application & inquiry)
    Website : http://www.orthope.com
    Location
    Khlong Preng Mueang Chachoengsao Chachoengsao
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