Quality System Engineer

BizLink Group; Batam; On-site; IDR 150,000,000 - 210,000,000; Full time

Job summary

BizLink Group is seeking a QA/QMS Document Control professional to ensure the integrity, availability, and controlled distribution of documents across ISO 9001, ISO 13485, and IATF 16949 environments. You will support internal/external audits, manage CAPA, and train staff on QMS procedures to maintain compliance.

The role requires 3+ years in manufacturing QMS, Mandarin and English fluency, and strong proficiency with Google Workspace tools for documentation and reporting.

Qualifications

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

Responsibilities

• Manage the distribution, revision, and storage of QMS documents and forms.
• Control document revisions and change logs; withdraw obsolete documents.
• Archive controlled documents with retention policies and ensure traceability.
• Provide documentation support during audits and ensure ISO compliance.
• Coordinate with departments for document creation and awareness; provide training.
• Operate Document Management Systems and perform data backups.

Skills

QMS knowledge

Internal audits

CAPA

Regulatory standards

Training

Mandarin

English

Communication skills

Education

Bachelor's degree in Administration or Engineering

Tools

Google Sheets

Google Docs

Google Slides

Job description

Responsible for ensuring 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).

• 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.
• Monitor and control document revisions, ensuring change logs are properly recorded. Withdraw or dispose of obsolete documents to prevent unintended use.
• Properly store and archive-controlled documents and quality records in accordance with document retention policies. Maintain document security, traceability, and ease of retrieval.
• 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.
• Coordinate with relevant departments for document creation, revision, and awareness. Provide basic training or guidance related to documentation control when needed.
• Operate Document Management Systems (DMS) or electronic filing tools.
• Ensure regular data backups and upkeep of digital document systems.

Job Requirements

• 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), experience with customer audits and supplier quality management.
• Fluent in Mandarin and English (speaking, reading, and typing are required).
• Proficient in Google Sheets, Google Docs, and Google Slides.
• 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.

BizLink is looking for the best & brightest talent

No matter the location, or the role, every BizLink employee shares one mission: Make interconnection easier to improve the quality of life and turn customers' innovative ideas into reality.