Quality Management System Specialist

Coordinate audit logistics, back- end preparation, document retrieval, and follow- up on findings.
Serve as a cross- functional compliance checkpoint for management review or inspection readiness.
Conduct internal audits and support external audits (ISO 13485, FDA 21 CFR Part 820, MDSAP).
Lead and schedule internal audits according to the QMS calendar.
Assist in CAPA effectiveness checks and regulatory readiness support.
Collaborate with functional departments to plan validations and risk assessment activities
Report and track QMS KPIs and drive continuous improvement initiatives.
Support layered audits, Gemba walks, and process walkthroughs.

Experience: At least 3 years in a similar role; experience in the medical device or other regulated industries is a plus.
Education: University degree
Skills:
Proficient in English skills.
Detail- oriented, responsible, and able to handle confidential information with integrity.
Understanding of document control practices and regulatory compliance.
Proficient in Microsoft Office (Word, Excel, Outlook, etc.).
Strong organizational, communication, and interpersonal skills.

Benefits & Compensation:

13th- month salary bonus & performance- based bonuses.
Health Insurance for employees + spouse and children.
Paid leave to care for family members.
Full participation in Social Insurance, Health Insurance, and Unemployment Insurance as per government regulations.
Annual health check- ups.
Various annual activities such as company trips, sports events, holiday gifts (Lunar New Year, Mid- Autumn Festival, Christmas, birthdays, International Children&039;s Day, International Women&039;s Day, Vietnamese Women&039;s Day, etc.).

We are committed to providing the best working environment for our employees — this is part of our core values. Your contributions are recognized, and you will share in the success you help create. Medtronic offers a range of benefits, support resources, and competitive compensation designed to support you throughout all stages of your career and life.
Medtronic offers a competitive salary and a flexible benefits package.

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Cập nhật gần nhất lúc: 2025-09-16 05:35:02