Document Control Specialist – ISO 9001/13485

Forefront Medical Investment Pte Ltd; Singapore; On-site; SGD 45,000 - 67,000; Full time

Job summary

Forefront Medical Investment Pte Ltd in Singapore seeks a QA Documentation Specialist to maintain ISO documentation, records and GDP compliance across the quality system. You will coordinate document revision, support audits, prepare Certificates of Conformity, and maintain quality records in a fast-paced medical device environment.

Fluent English and Chinese translation skills are required to communicate with Chinese-speaking clients, suppliers and partners.

Qualifications

• GCE O 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.
• Writing manufacturing procedures and GMP requirements.
• Maintaining quality records.
• Effective communication and interpersonal skills.
• ISO 9001 & ISO 13485 requirements.

Responsibilities

• Maintain ISO documentation and records to ensure traceability and compliance.
• Monitor NCR, CAPA, CCR, CRF, SCAR, validation protocols and audit reports.
• Coordinate controlled document revision, distribution and retrieval.
• Conduct training on document creation and control procedures.
• Review documents for GDP compliance.
• Coordinate annual document location audits and reviews.
• Assist internal and external quality system audits.
• Copy, scan, filing, archive, and backup of documents.
• Prepare and issue Certificates of Conformity.
• Prepare monthly trend analysis reports.
• Maintain retained samples and records.
• Perform other duties as assigned.

Skills

English translation

Chinese translation

Effective communication

Interpersonal skills

Education

GCE O level or higher Diploma in engineering

Job description

Forefront Medical Investment Pte Ltd in Singapore seeks a QA Documentation Specialist to maintain ISO documentation, records and GDP compliance across the quality system. You will coordinate document revision, support audits, prepare Certificates of Conformity, and maintain quality records in a fast-paced medical device environment.

Fluent English and Chinese translation skills are required to communicate with Chinese-speaking clients, suppliers and partners.