Mô tả công việc
Job Objective
Responsible for maintaining, implementing, and continuously improving the company’s Quality Management System to ensure compliance with ISO 9001, ISO 13485, customer requirements, and applicable regulatory standards.
Key Responsibilities
- Maintain and continuously improve the Quality Management System, including relevant procedures, work instructions, records, and supporting documentation.
- Coordinate the implementation of and compliance with ISO 9001 and ISO 13485 requirements across relevant functions.
- Plan and conduct internal audits and coordinate certification audits, customer audits, and other external assessments.
- Monitor audit findings, non-conformities, CAPA activities, and corrective actions to ensure timely closure and effective implementation.
- Manage quality-related documents and records in accordance with established document control requirements.
- Coordinate risk assessments, quality objectives, KPI monitoring, and continuous improvement initiatives.
- Deliver ISO and QMS awareness training and provide guidance to departments in implementing quality system requirements.
- Prepare QMS reports and support Management Review activities.
- Monitor updates to applicable standards and regulatory requirements and ensure necessary actions are implemented accordingly.
- Request relevant departments to provide information and documentation required for QMS and audit activities.
- Recommend improvements to QMS procedures, processes, and related documentation.
- Request and follow up on corrective actions for identified non-conformities and promptly escalate significant quality risks or compliance issues to management.
- Perform other duties as assigned by direct supervisors.
Requirements
Education
- Bachelor’s degree in Engineering or another relevant discipline.
Experience
- At least 3 years of experience in Quality Management or QMS within a manufacturing environment.
- Strong knowledge and hands‑on experience with ISO 9001 and ISO 13485.
- Experience with ISO 14001 and ISO 45001 is considered an advantage.
- Practical experience in QMS implementation, internal audits, and external or customer audits is required.
- Good command of English for professional communication and documentation.
Technical Skills
- Proficiency in Microsoft Office.
- Experience using quality management systems or electronic document management tools is an advantage.
Personal Competencies
- Strong analytical, problem‑solving, communication, and cross‑functional coordination skills.
- Proactive, responsible, and systematic, with the ability to work effectively and independently.