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Join us to learn from and with us, to teach us, to create somethings together that is truly ours.

Quality Manager

(Training Provided)

Location: Our office is conveniently located near MRT Samyan, Samyan Mitrtown

Role Overview:

We’re looking for a Quality Manager to lead our ISO 13485 compliant QMS, drive continuous improvement, and keep us audit ready. You’ll manage documentation, CAPAs, and support a small but dedicated quality team while working closely with teams across the company to keep quality deeply integrated into everything we do. To help you step confidently into the role, you’ll receive hands-on training and support from our current QMR. If you’re systems-minded, detail-driven, and inspired by purpose, you’ll feel right at home here.

Key Responsibilities:

  1. ​Quality Management System (QMS) Oversight:
    Lead the development, implementation, and maintenance of the QMS to ensure compliance with ISO 13485, and Thai FDA regulations.
     

  2. Documentation Control & Audits:
    Ensure all regulatory and quality management documentation, including SOPs, work instructions, and regulatory filings, are up to date and compliant with industry standards. Conduct internal audits and assist in preparing for external audits.
     

  3. Continuous Improvement & CAPA Management:
    Lead and manage the CAPA (Corrective and Preventive Actions) process and continuously improve quality systems and processes within the organization.
     

  4. Team Management:
    Supervise and manage 1–2 team members in regulatory affairs and quality management. Ensure task completion, maintain high performance standards, and oversee their day-to-day responsibilities.

Qualifications:

  • Master's degree or PhD in Biomedical Engineering, Sciences or related fields.

  • Familiarity or some hands-on experience with Quality Management Systems (QMS), particularly ISO 13485, and Thai FDA requirements is a plus.

  • Quick learner with the ability to absorb complex regulatory and quality-related information and apply it effectively. 

  • Fluent in both Thai and English, with excellent written and verbal communication skills in both languages.

  • Strong analytical, organizational, and problem-solving skills.

  • Ability to work independently while managing and developing a small team and collaborating effectively with cross-functional teams.

  • High attention to detail and a commitment to maintaining regulatory compliance and high-quality standards in the medical device industry.​

Why Join Us:

  • Growth Opportunities: Be part of a rapidly expanding company where you can directly influence the quality and compliance of innovative medical devices.

  • Training & Development: Work closely with experienced leaders, including our current QMR, who will provide mentorship and hands-on training.

  • Impactful Work: Take ownership of key regulatory and quality management processes, ensuring the safety and efficacy of products that improve lives.

Salary and Compensation

  • Base Salary: THB 35,000 to THB 45,000 

  • Performance-Based Bonus 

  • Other benefits

How to Apply:

If you're excited about this opportunity and ready to make a meaningful impact in the medical device industry, we encourage you to apply! Please submit your CV and a brief cover letter outlining your qualifications and why you're interested in this role to info@popolo.health

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