QA & Compliance Coordinator - Fast-Paced Medical Devices

BIOPTIMAL INTERNATIONAL PTE. LTD.; Singapore; On-site; SGD 47,000 - 71,000; Full time

Job summary

BIOPTIMAL INTERNATIONAL PTE. LTD. seeks a QA professional to manage customer complaints, QA investigations, and regulatory submissions. The role supports UDI registration, COO processing, and document control across the quality system.

The ideal candidate has 1 year QA experience in a fast-paced setting, strong English communication, and familiarity with ISO 9001/13485. Prior medical device exposure is a plus; independent work style is valued.

Qualifications

• Bachelor/Graduate with 1 year QA exposure in a fast-paced setting.
• Fluent in spoken and written English.
• ISO 9001 or ISO 13485 knowledge is preferred.
• Document control systems experience is a plus.
• Experience in medical device QA is advantageous.
• Strong interpersonal and communication skills.

Responsibilities

• Handle customer complaints; ensure investigations are completed without delay.
• Escalate and report compliant cases to relevant regulatory portals as required.
• Register product UDI across databases (e.g., EUDAMED, GUDID, GS1).
• Coordinate creation and endorsement of COO with Chamber of Commerce.
• Ensure product inspection and lot release when QA Inspector unavailable.
• Monitor warehouse temperature/humidity per schedule and assist pest-control activities.
• Verify calibration of measuring devices before expiry.
• Coordinate document translation for accuracy.

Skills

Quality Assurance

English Fluency

Document Control

Communication Skills

Self-starter

Education

Science Graduate

Tools

QMS System

Job description

BIOPTIMAL INTERNATIONAL PTE. LTD. seeks a QA professional to manage customer complaints, QA investigations, and regulatory submissions. The role supports UDI registration, COO processing, and document control across the quality system.

The ideal candidate has 1 year QA experience in a fast-paced setting, strong English communication, and familiarity with ISO 9001/13485. Prior medical device exposure is a plus; independent work style is valued.