Omron Healthcare Manufacturing ★ 1.5

Mô tả Công việc

1. Leading QA team to execute Quaity activities:

- Define and implement short-term quality strategy for the factory.

- Set Quality strategy in compliance with QMS according to ISO 9001, ISO 13485, FDA Part 820 standards, and customer requirements.

2. Owner Overall product quality control from incoming → in-process → outgoing → customer.: Ensure compliance with regulatory and customer-specific requirements

3. Response and handling complaints from markets and quality issue

4. Oversee supplier quality, defining requirements and monitoring incoming materials or components.

- Participate in and coordinate activities to improve raw material quality

- Manage supplier quality including supplier audit (QMS, Process, CMS)

5. Partcipating in assess and control risk for new products or changes (DR, 4M change)

6. Ensure effective CAPA closure and shift from corrective to preventive control mindset.

7. Continuous Improvement

8. Oversee IQC/ OQC teams, including managing expenses and human resources.

Yêu Cầu Công Việc

Education: Bachelor's degree in Quality Assurance/ Internal audit , have certificate of ISO 9001, ISO 14001, ISO 13485, and QC3 or related fields.
Experience: 

• At least 5 year in  Quality  field, or from 3 years of similar position

• Knowledge of Quality Management Systems (QMS) according to ISO 9001, ISO 13485, and FDA Part 820 standards.
• English or Japan communication

Interview round: 1st round with Direct Manager, Final round with General Director