QMS Engineer

Duties/Responsibilities

• Document Management – Manage distribution, revision, and storage of ISO 9001, ISO 13485, and IATF 16949 documents including quality manual, procedures, work instructions, and forms. Ensure current versions are available at points of use.
• Document Revision Control – Monitor and control document revisions, ensuring change logs are properly recorded. Withdraw or dispose of obsolete documents to prevent unintended use.
• Filing and Archiving – Store and archive controlled documents and quality records in accordance with retention policies. Maintain document security, traceability, and ease of retrieval.
• Audit Support and Compliance – Provide documentation support during internal and external audits (e.g., ISO surveillance audits). Assist in ensuring compliance with ISO 9001, ISO 13485, and IATF 16949 documentation requirements.
• Cross-Department Coordination – Coordinate with relevant departments for document creation, revision, and awareness. Provide basic training or guidance related to documentation control when needed.
• Document Management Systems – Operate DMS or electronic filing tools, ensuring regular data backups and upkeep of digital document systems.

• Bachelor’s degree in Administration, Engineering, or a related field.
• At least 3 years of experience in Quality Management Systems (QMS) within a manufacturing environment.
• Strong working knowledge of ISO 9001, IATF 16949, ISO 13485, and ISO 22301 requirements.
• Proven experience conducting internal audits, supporting external audits, and managing corrective and preventive actions (CAPA), including customer audits and supplier quality management.
• Fluent in Mandarin and English (speaking, reading, and typing).
• Proficient in Google Sheets, Google Docs, and Google Slides.
• Knowledge of regulatory standards relevant to the industry.
• Experience training employees on QMS procedures.
• Detail-oriented, highly organized, and able to work with confidential information.
• Strong communication and interpersonal skills.