QA Specialist

MVC Resources Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

QA Specialist

Location : Malaysia Operations (Travel required to Philippines as needed)

Overview

Quality Assurance Specialist (Individual Contributor) is a critical, high-impact role responsible for spearheading and maintaining all Quality Assurance (QA) systems and regulatory compliance for our client\'s health and wellness products, within the Malaysian and SEA markets.

The Engineer serves as the local QA expert, ensuring continuous compliance with ISO 9001 (as the core system), GDPMD, and local registration requirements for Medical Devices, Food Supplements, Pharmaceuticals, and Cosmetics. This role is ideal for a proactive, self-motivated professional with strong commercial quality experience in the medical or healthcare industry.

Key Responsibilities & Expectations

• QA System Maintenance & Audits (Spearhead Role)

QMS Integrity : Act as the spearhead for the local Quality Management System (QMS), ensuring continuous maintenance and compliance with ISO 9001 and other relevant standards (e.g., ISO 13485, GDPMD, EU GMP).

Product Registration : Manage the registration of new products and maintain all existing product registration records and files for Medical Devices (specifically in Malaysia), Food Supplements, Pharmaceuticals, and Cosmetics.

Documentation Control : Manage the document change order (DCO) process for both internal teams and contract distribution organizations.

Requirements

Candidate Requirements

Education & Experience

Hard Requirements & Expertise

Soft Skills & Work Style

Seniority level

Employment type

Job function

Industries

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