Quality Director(Aws iso 13485)

1 week ago

Johor Bahru, Malaysia MINDe Group Full time

**Job Scope**:
The **Quality Director** will lead and oversee all quality assurance, compliance, and continuous improvement initiatives to ensure the highest product quality, regulatory compliance, and customer satisfaction. This role is responsible for developing and implementing strategic quality objectives, enhancing operational efficiency, and maintaining compliance with global medical device regulations and industry standards.

**Key Responsibilities**:

- Develop, implement, and maintain the **Quality Management System (QMS)** in compliance with **ISO 13485, FDA 21 CFR Part 820, MDR (EU), MDSAP, and other relevant regulatory requirements**.
- Ensure adherence to **Good Manufacturing Practices (GMP)** and **Good Documentation Practices (GDP)**.
- Lead **internal and external audits** and manage relationships with regulatory bodies, ensuring successful certifications and approvals.
- Oversee **supplier quality management**, including supplier audits, qualification, and performance monitoring.
- Drive **quality improvement initiatives**, including **Six Sigma, Lean Manufacturing, and Root Cause Analysis (RCA)** methodologies.
- Monitor **Key Performance Indicators (KPIs)** related to product quality, defects, and non-conformances, ensuring corrective and preventive actions (CAPA) are effectively implemented.
- Champion a **Zero Defect Culture**, ensuring process standardization and optimization to reduce waste and inefficiencies.
- Lead and mentor a team of **Quality Engineers, Quality Assurance (QA) Managers, and Inspectors**, fostering a culture of accountability and excellence.
- Collaborate with **R&D, Engineering, Manufacturing, and Supply Chain** teams to integrate quality into every stage of product development and production.
- Provide training and awareness programs on **quality standards, regulatory requirements, and best practices**.
- Address **customer complaints, warranty issues, and field failures**, ensuring timely investigations and resolution.
- Act as the primary point of contact for **regulatory authorities, notified bodies, and external auditors**.
- Develop and present **quality performance reports** to senior leadership, driving informed decision-making.

**Job Requirements**:

- **Bachelor’s or Master’s degree** in **Engineering, Quality Management, or a related field**.
- Minimum **10-15 years** of experience in **quality management**, preferably in a **medical device, electronics manufacturing environment**.
- Strong understanding of **ISO 13485, FDA regulations, MDR, and other medical device standards**.

Pay: Up to RM23,000.00 per month

Schedule:

- Monday to Friday

Supplemental Pay:

- 13th month salary
- Performance bonus

Work Location: In person

Expected Start Date: 03/31/2025

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