QA Manager

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

**Essential Duties and Responsibilities**
**Role Summary:**
Plan and drive overall quality assurance, manufacturing control, and safety management activities for handled products and services in compliance with QMS, GVP, and the Pharmaceuticals and Medical Devices Act (PMD Act).

**Job Description**

**Scope of Products:**

+ In vitro diagnostics, medical devices, research-use products, and consumables imported and distributed by Thermo Fisher Diagnostics K.K. (TFD)
+ Product portfolio includes allergy-related products, autoimmune disease products, protein diagnostics, biomarker-related products, quality control materials, and microbiological testing products

**1. Key Responsibilities:**

+ Based on business plans, anticipate and evaluate risks associated with new products and services, establish proc...