QC Technician

Quasar Medical (Singapore) Pte Ltd; Singapore; On-site; SGD 30,000 - 45,000; Full time

Job summary

A leading medical device company in Singapore is seeking a QC technician responsible for supporting quality activities, including inspections and documentation compliance. Ideal candidates have 1-2 years of experience in quality roles within medical device manufacturing. Strong communication skills in English and familiarity with FDA regulations and ISO 13485 standards are essential. The role offers opportunities for continuous improvement and collaboration within a multicultural team.

Qualifications

• 1–2 years of quality responsibility in medical device or pharmaceutical manufacturing.
• Excellent written and oral communication skills in English.
• Knowledge of FDA regulations and ISO 13485 standards.

Responsibilities

• Conduct inspections of raw materials, components, and packaging.
• Complete inspection records and adhere to quality standards.
• Collaborate with production to ensure ongoing quality.

Skills

Quality control inspections

Documentation compliance

Effective communication

Team collaboration

Education

GCE 'O' level or equivalent

Diploma in related field

Tools

QC instruments (calipers, micrometers, etc.)

MS Office

Job description

Job Summary:

The QC technician is responsible for supporting quality activities within Quasar Medical Singapore Operations. This will include support for new product development and transfers.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

Inspection & Testing

• Perform / guiding QC Inspectors in conducting incoming inspection of raw materials, components, and packaging materials using established procedures.
• Perform / guiding QC Inspectors in conducting in-process and final product inspections, including dimensional checks, functional testing, and visual inspections.
• Operate and maintain QC instruments (e.g., calipers, micrometers, microscopes, tensile testers, vision systems, SmartScope, etc.).
• Record test data accurately and ensure traceability in compliance with GDP (Good Documentation Practices).
• Involve in the establishment of test method and be the trainer to guide QC inspectors performing the testing.

Documentation & Compliance

• Complete inspection records, test reports, and nonconformance reports in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements.
• Ensure proper labeling, segregation, and disposition of accepted/rejected materials.
• Assist in investigation of nonconformities, deviations, and customer complaints.
• Support Corrective and Preventive Actions (CAPA) and change control processes.

Process Support

• Collaborate with production to ensure in-process quality is maintained.
• Routinely audit the production line to ensure GMP practices are in place, and operators follow documented process instruction.
• Escalate quality issues to QC Supervisor/Quality Engineer for disposition.
• Participate in equipment calibration and preventive maintenance programs.
• Support process validations and verification activities.

Continuous Improvement

• Contribute to improvement of inspection methods and sampling plans.
• Provide feedback to engineering and production teams on quality issues and trends.
• Participate in internal audits, training, and quality improvement initiatives.

Education/Experience and Qualifications:

• GCE “O” level or equivalent, Diploma preferred, with 1~2 years of progressive Quality responsibility preferably in Medical Device / Pharmaceutical Manufacturing.
• Excellent Communication Skills. English written & oral communication skills are a must.
• Computer literate (MS Office).
• Knowledgeable in reading and/or writing manufacturing procedures and GMP requirements.
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards is a plus.
• Willing to work in a multi-cultural team and in a clean room environment.
• Willing to work in shift.