Quality Management System Specialist

Mô tả Công việc

• Lead and schedule internal audits according to the QMS calendar.
• Coordinate audit logistics, back-end preparation, document retrieval, and follow-up on findings.
• Conduct internal audits and support external audits (ISO 13485, FDA 21 CFR Part 820, MDSAP).
• 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.
• Assist in CAPA effectiveness checks and regulatory readiness support.
• Serve as a cross-functional compliance checkpoint for management review or inspection readiness.

Yêu Cầu Công Việc

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

Benefits & Compensation:

• 13th-month salary bonus & performance-based bonuses.
• Full participation in Social Insurance, Health Insurance, and Unemployment Insurance as per government regulations.
• Health Insurance for employees + spouse and children.
• Paid leave to care for family members.
• 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's Day, International Women's Day, Vietnamese Women's Day, etc.).

Medtronic offers a competitive salary and a flexible benefits package.

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.