About the Role
We are seeking a detail-oriented Quality Technician to support quality assurance and laboratory operations for medical device components. You will play a key role in ensuring product quality, regulatory compliance, and maintaining an audit-ready environment.
Key Responsibilities
Quality Management System (QMS)
- Prepare and maintain quality documentation such as Certificates of Analysis (CoA), inspection reports, and traceability records
- Ensure compliance with ISO 13485, internal procedures, and customer requirements
- Support internal and external audits by preparing documentation and providing inspection/testing data
- Maintain a clean, safe, and audit-ready QC environment
Quality Operations & Lab Testing
- Perform routine QC laboratory testing based on product control plans
- Conduct incoming, in-process, and outgoing inspections using approved methods
- Ensure accurate and timely recording of inspection and quality data
Equipment Calibration & Measurement
- Perform calibration and verification of measurement equipment
- Maintain calibration records and ensure equipment compliance
- Identify and report equipment issues and coordinate corrective actions
Continuous Improvement
- Participate in Lean / 5S and process improvement initiatives
- Identify opportunities to reduce defects and improve inspection efficiency
- Support initiatives to enhance QMS compliance
Non-Conformance & Investigation
- Support failure investigations, including re-testing and root cause analysis
- Document non-conformances and assist in CAPA implementation
- Participate in containment and corrective actions
Business Edge Personnel Services Singapore
EA License No: 96C4864
EA Personnel Reg No: R26159908 (Tan Ying Ying)
