Quality Inspector

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 42,000 - 64,000; Full time

Job summary

QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking a QC Inspector to support quality activities, including new product development and transfers, within Quasar Medical Singapore Operations.

You will assist in incoming, in-process, and final inspections, contribute to calibration and maintenance systems, and help ensure compliance with GMP, ISO13485, and FDA CFR Part 820 requirements in a multi‑disciplinary team environment.

Qualifications

• 1–2 years of progressive Quality responsibility preferably in Medical Device / Pharmaceutical Manufacturing.
• Excellent English communication (written and oral).
• Computer literate (MS Office).
• Knowledgeable in reading/writing manufacturing procedures and GMP requirements.

Responsibilities

• Support the implementation of standards and procedures for incoming inspection of materials and components, for in-process assessment of work in progress (WIP), and for final/outgoing inspection & lot release of finished products.
• Perform receiving (incoming) inspection for raw materials and in-process / outgoing inspection / lot release of finished products.
• Assist product quality engineer in the investigation and analysis of quality issues.
• Assist product quality engineer in the maintenance of the calibration/ preventive maintenance systems.
• Assist product quality engineer in the qualification/ validation processes and the development of protocols in conjunction with appropriate functions.
• Review and approval of quality records including inspection reports, lot history records.
• Perform testing, and evaluation, which includes sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.
• Participate in the non-conforming materials review (NCMR) process to ensure that non-conforming products are properly handled.
• Maintain and comply with the requirements of ISO13485, GMP and CFR Part 820 (FDA) regulations.

Skills

Communication

English Proficiency

GMP knowledge

Regulatory knowledge

Education

GCE 'O' level

Diploma

Tools

MS Office

Job description

Job Summary:

The QC Inspector 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.

• Support the implementation of standards and procedures for incoming inspection of materials and components, for in-process assessment of work in progress (WIP), and for final/outgoing inspection & lot release of finished products.
• Perform receiving (incoming) inspection for raw materials and in-process / outgoing inspection / lot release of finished products.
• Assist product quality engineer in the investigation and analysis of quality issues.
• Assist product quality engineer in the maintenance of the calibration/ preventive maintenance systems.
• Assist product quality engineer in the qualification/ validation processes and the development of protocols in conjunction with appropriate functions.
• Review and approval of quality records including inspection reports, lot history records.
• Perform testing, and evaluation, which includes sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.
• Participate in the non-conforming materials review (NCMR) process to ensure that non-conforming products are properly handled.
• Maintain and comply with the requirements of ISO13485, GMP and CFR Part 820 (FDA) regulations.

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.