QMS Engineer

Job Summary:

To ensure effective control of documented information in accordance with ISO 9001 standards, maintaining the accuracy, availability, and integrity of documents and records used in the Quality Management System (QMS).

Duties/Responsibilities:

1. Document Management

Manage the distribution, revision, and storage of all ISO 9001, ISO 13485 and IATF 16949 documents including quality manual, procedures, work instructions, and forms. Ensure that current versions of documents are available at points of use.

2. Document Revision Control

Monitor and control document revisions, ensuring change logs are properly recorded. Withdraw or dispose of obsolete documents to prevent unintended use.

3. Filing and Archiving

Properly store and archive-controlled documents and quality records in accordance with document retention policies. Maintain document security, traceability, and ease of retrieval.

4. 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.

5. Cross Department Coordination

Coordinate with relevant departments for document creation, revision, and awareness. Provide basic training or guidance related to documentation control when needed.

6. Digital Document Systems

Operate Document Management Systems (DMS) or electronic filing tools Ensure regular data backups and upkeep of digital document systems.

Requirements:

• Bachelor’s degree in Administration, Engineering, or a related field.

• At least 3 years of experience in 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), experience with customer audits and supplier quality management

• Fluent in Mandarin and English (speaking, reading, and typing are required).

• Proficient in Google Sheet, Google Docs, and Google Slide

• Knowledge of regulatory standards relevant to the industry

• Experience in training employees on QMS procedures

• Detail-oriented, highly organized, and able to work with confidential information

• Strong communication and interpersonal skills