Document Control Specialist — ISO 9001/13485 & GDP Compliance

Forefront Medical Investment Pte Ltd; Singapore; On-site; SGD 40,000 - 65,000; Full time

Job summary

Forefront Medical Investment Pte Ltd in Singapore is seeking a detail‑oriented Quality Documentation Specialist to uphold and control quality system records in line with ISO 9001/13485 and GDP standards. You will manage document revisions, perform training on control procedures, and support audits with strong English/Chinese communication.

You will prepare Certificates of Conformity, maintain logs, and generate monthly trend analyses while ensuring traceability and regulatory compliance across

Qualifications

• GCE/O level or higher Diploma in engineering is preferred.
• Minimum 2 years in maintaining ISO documentation, preferably in medical device manufacturing.
• Proficient in English and Chinese translation for client communication.
• Experience writing manufacturing procedures and GMP requirements.
• Maintaining quality records and effective internal/external communication.
• Familiarity with ISO 9001 and ISO 13485 standards.

Responsibilities

• Upkeep Quality System documentation and records to ensure traceability and compliance.
• Maintain logs and monitor NCR, CAPA, CCR, CRF, SCAR, validation, and audit related docs.
• Coordinate controlled document revision, distribution, and retrieval.
• Conduct training on document creation and control procedures.
• Review documents for GDP compliance.
• Coordinate yearly document location audits and procedures reviews.
• Assist internal and external quality system audits.
• Copy, scan, file, archive and back up documents.
• Prepare and issue Certificate of Conformity (COC).
• Prepare monthly trend analysis reports.
• Maintain retain samples and records.
• Perform any other duties as assigned.

Skills

English-Chinese translation

Write procedures & GMP

Quality documentation maintenance

Effective communication

ISO 9001 & ISO 13485 familiarity

Diploma in engineering

GCE O level or higher

Education

GCE O level or higher Diploma in engineering

Job description

Forefront Medical Investment Pte Ltd in Singapore is seeking a detail‑oriented Quality Documentation Specialist to uphold and control quality system records in line with ISO 9001/13485 and GDP standards. You will manage document revisions, perform training on control procedures, and support audits with strong English/Chinese communication.

You will prepare Certificates of Conformity, maintain logs, and generate monthly trend analyses while ensuring traceability and regulatory compliance across