Document Control Specialist, Quality Systems

Quasar Medical; Singapore; On-site; SGD 42,000 - 60,000; Full time

Job summary

Quasar Medical is seeking a Clerk, Document Control to supervise QA documentation activities at our Singapore site. You will ensure controlled documents are current, accessible, and properly archived to support regulatory compliance and product release.

Responsibilities include training staff on standards, supporting NPIs, and assisting audits. A technical diploma with 3–5 years of experience in medical devices is preferred, along with strong IT skills and attention to detail.

Qualifications

• GCE "O" Level or higher; Diploma preferred in a technical field or equivalent, with 3–5 years of progressive experience in maintaining quality records and quality systems, preferably in Medical Device Manufacturing.
• Experience in developing, enhancing, implementing, and maintaining a documentation system that demonstrates regulatory compliance, or similar document creation, filing, and/or archiving.
• Excellent communication skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint; experience with electronic filing, database administration and/or CAD software drawing.
• Knowledge of ISO 9001, ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directive.

Responsibilities

• Lead and supervise document control activities for QA and NPI deliverables.
• Ensure current revision of controlled documents; remove obsolete files from use.
• Train personnel on documentation standards and practices.
• Assist in Change Plans and ECO packets for compliance with requirements.
• Support internal and external audits of the Quality System.
• Maintain Design History Files, validation and test reports, and related records.
• Manage SCAR, NC, CAPA, complaints and RMA processes.

Skills

Documentation control

Quality systems

Communication skills

Independent work

Education

GCE O Level or higher

Technical Diploma

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

CAD software drawing

Database administration

Job description

Quasar Medical is seeking a Clerk, Document Control to supervise QA documentation activities at our Singapore site. You will ensure controlled documents are current, accessible, and properly archived to support regulatory compliance and product release.

Responsibilities include training staff on standards, supporting NPIs, and assisting audits. A technical diploma with 3–5 years of experience in medical devices is preferred, along with strong IT skills and attention to detail.