Assistant Quality Engineer (QMS)

Summary

Job Description

Oversees the document management process includes effectively storing the documents, maintaining access, ensuring the security of the documents and controlling the sending and receiving of documents. Manage the documents according to standard regulations within the company and legal.

Job Responsibilities

1. Review records to assure adherence to ISO 13485 compliance administration.
2. Perform quality checks on documents to ensure compliance to Good Documentation Practices.
3. Coordinating internal, external audit and management review meeting.
4. Manage and monitor internal and external document control processes.
5. Coordinate Non-Conformance and CAPA processes related to manufacturing and internal/external audit.
6. Ensure all documentation is up to date and accurate.
7. Manage document filing, distributing and archiving processes.
8. Perform any other related duties as assigned by immediate superior.

Qualifications

1. Education level: Minimum Bachelor’s degree in Science or Engineering (or any relevant discipline).
2. Year(s) of Experience: Minimum one year experience in manufacturing / Fresh graduate.
3. Capability: Effective communication skills and proficiency in Japanese language.
4. Skills: Knowledge in MasterControl QMS System. Proficiency in documentation tools, such as Microsoft Word, Excel and PowerPoint.
5. Language: English, Bahasa, Japanese (Good to have).