QE Technician

Quasar Medical (Singapore) Pte Ltd; Singapore; Presencial; SGD 40.000 - 54.000; Jornada completa

Descripción de la vacante

Quasar Medical Singapore is seeking a Quality Engineer/Technician to support quality activities across new product development and transfers. The role emphasizes inspection, testing, and documentation to ensure GDP-compliant traceability.

The incumbent will guide QC inspectors in incoming, in-process, and final product inspections, operate calibration programs, and contribute to CAPA and change control processes. English communication and GMP knowledge are essential.

Formación

• GCE 'O' level or Diploma with 1–2 years in quality roles in Medical Device / Pharmaceutical manufacturing.
• Strong written and spoken English.
• Familiar with GMP and ISO/FDA regulatory requirements.

Responsabilidades

• Guide QC Inspectors in incoming material inspections and testing.
• Oversee in-process and final product inspections and documentation.
• Maintain traceability and GDP-compliant records.
• Support CAPA, change control, and calibration activities.
• Collaborate with production to uphold GMP practices.

Conocimientos

Communication skills

English proficiency

GMP knowledge

Educación

GCE O level

Diploma

Herramientas

MS Office

Descripción del empleo

Job Summary:

The QE 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 the GMP practices is in place, and operators are following 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