Job Description

Our client is a leading medical device manufacturer in Thailand, with over 36 years of expertise.

Job Summary:

The Quality Manager in the medical device industry will be responsible for managing the full spectrum of quality activities, ensuring that the company’s products meet the highest quality standards. This includes overseeing customer quality, supplier quality, and in-process quality. The role will involve managing the Quality Management System (QMS), leading internal audits, handling customer complaints, and ensuring compliance with ISO 13485. The individual will be responsible for promoting continuous improvement and maintaining a clean room environment for manufacturing operations. Additionally, this role will involve handling export-related quality compliance and product quality monitoring.

Key Responsibilities:

• Developing, implementing, and maintaining the company’s QMS to ensure compliance with ISO 13485, regulatory requirements, and industry standards.
• Serving as the Quality Management Representative (QMR) and ensuring that the QMS is followed throughout the organization.
• Managing and resolving customer complaints, ensuring timely response and resolution in accordance with regulatory requirements.
• Overseeing supplier audits and quality assessments, ensuring compliance with product specifications and regulatory requirements.
• Monitoring and controlling quality during manufacturing processes to ensure compliance with specifications and standards.
• Overseeing the development of inspection criteria and ensuring that all in-process inspections are carried out as per the QMS and regulatory standards.
• Planning, executing, and reporting on internal audits to ensure compliance with ISO 13485 and internal quality standards.
• Driving continuous improvement initiatives throughout the quality system and operations to optimize product quality, minimize defects, and enhance customer satisfaction.
• Ensuring that products meet the necessary regulatory requirements for export, including compliance with international standards and country-specific regulations.

Qualifications:

• Bachelor’s degree in engineering, Life Sciences, or a related field (master’s degree preferred).
• Experience in quality management roles within the medical device industry.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Extensive experience in QMS, QA, QC, 8D methodology, and internal audits.
• Experience in handling customer complaints, root cause analysis, and corrective implementation.
• Strong communication and interpersonal skills with the ability to communicate effectively in English.
• Proven leadership skills and the ability to drive continuous improvement.