Document Controller

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

Job Description:

1. Upkeep Quality System documentation and records in ensuring traceability, integrity, accessibility, in compliance to corporate policies, regulatory and customer requirement.

2. Maintain log sheet, monitor and follow up on Non-conformance Report (NCR), Corrective and Preventive Action (CAPA), Customer Complaint Report (CCR), Change Request Form (CRF), Supplier Corrective Action Request (SCAR), Validation Protocol & Report and Audit Report.

3. Coordinate controlled document revision, distribution and retrieval as per document change control

4. Conduct training for document creation and document control procedure and processes

5. Review document for GDP and ensure compliance.

6. Coordinate the document location distribution audit and procedure yearly review.

7. Assist internal and external quality system audits

8. Copy, scan, filing, archive, backup of documents

9. Prepare and issue Certificate of Conformity (COC)

10. Prepare monthly trend analysis report

11. Maintain retain sample and records.

12. Any other duties as assigned

Job Requirement:

• GCE ‘Ó’ level or higher Diploma in engineering preferred

• Minimum 2 years working experience in maintaining ISO documentation, preferably in medical device manufacturing

• Proficient in English and Chinese translation. "We are seeking candidates proficient inChineseto effectively communicate withChinese-speaking clients."

• Writing manufacturing procedures and GMP requirement

• Maintaining quality record

• Effective communication skill and interpersonal skill

• ISO 9001 & ISO 13485 requirements