QC Inspector (Night shift)

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 30,000 - 45,000; Full time

Job summary

A medical device company in Singapore is seeking a QC Inspector responsible for supporting quality activities within operations. The role involves implementing standards for material inspection, assisting in quality issue investigation, and maintaining compliance with ISO13485 and FDA regulations. Ideal candidates should possess GCE 'O' level qualifications, 1-2 years of quality experience in medical device manufacturing, and strong communication skills. The position requires work in a multi-cultural team and cleanroom environment.

Qualifications

• 1-2 years of quality responsibility in Medical Device or Pharmaceutical Manufacturing.
• Knowledge of regulatory requirements and quality standards including FDA and ISO 13485.
• Ability to read/write manufacturing procedures and GMP requirements.

Responsibilities

• Support implementation of standards for incoming inspection and final product release.
• Perform incoming inspection for raw materials and finished products.
• Assist in the investigation and analysis of quality issues.

Skills

Excellent Communication Skills

Knowledge in ISO 13485

Computer Literacy (MS Office)

Ability to work in a multi-cultural team

Education

GCE 'O' level or equivalent

Diploma preferred

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.