ISO Consultant - Healthcare & Medical Devices

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Healthcare & Medical Full-Time
ISO Consultant - Healthcare & Medical Devices
Ho Chi Minh City
Healthcare & Medical
Full-Time
Back to Careers
Healthcare & Medical Full-Time
ISO Consultant - Healthcare & Medical Devices
Ho Chi Minh City
Healthcare & Medical
Full-Time
Role Overview
Vietnam's healthcare and medical device sector is undergoing rapid modernization, driven by government investment, international partnerships, and growing domestic demand for quality healthcare services. UPLYFT360° Vietnam is seeking a specialist ISO Consultant for our Healthcare & Medical Devices practice - supporting hospitals, clinics, medical laboratories, medical device manufacturers, and testing and calibration laboratories in achieving internationally recognized quality management certifications.
Key Responsibilities
Lead ISO 13485 Medical Devices Quality Management System implementation projects
Support medical and clinical laboratories in achieving ISO 15189 accreditation
Guide testing and calibration laboratories through ISO/IEC 17025 accreditation preparation
Develop quality management documentation tailored to healthcare and medical regulatory requirements
Conduct training on ISO 13485, ISO 15189, and ISO/IEC 17025 requirements for healthcare professionals
Perform internal audits and gap assessments against applicable standards
Advise on Vietnamese regulatory requirements for medical devices (Ministry of Health circulars)
Support validation and verification activities for medical device manufacturing clients
Coordinate with accredited certification and accreditation bodies for assessment scheduling
Requirements
1 Minimum 3 years of experience in healthcare quality consulting or healthcare quality management
2 ISO 13485 Lead Auditor or equivalent certification
3 Working knowledge of ISO 15189 and ISO/IEC 17025 requirements
4 Understanding of Vietnamese Ministry of Health regulatory requirements for medical devices and healthcare
5 Fluent Vietnamese and proficient English
6 Healthcare, medical, pharmacy, or life sciences educational background preferred
7 Strong attention to detail and documentation discipline
Preferred Qualifications
Experience with GMP for pharmaceutical or medical device manufacturing
Familiarity with CE marking or FDA 510(k) regulatory pathways
ISO 17025 Lead Assessor qualification
Clinical laboratory or hospital quality management background
What We Offer
Attractive salary package with healthcare specialist premium
Sponsorship for ISO 13485 Lead Auditor certification
Opportunity to work with Vietnam's leading hospitals, clinics, and medical device companies
Continuous professional development in a rapidly evolving specialist field
Contribution to improving healthcare quality standards across Vietnam
Apply Now
Submit your application and we'll be in touch within 5 business days.
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ISO Consultant - Healthcare & Medical Devices
Healthcare & Medical
Ho Chi Minh City Apply Now Back to Careers
Phone
+84 38 207 0084
Email
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