Medical Device QC Inspector – ISO 13485 Quality

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 40,000 - 54,000; Full time

Job summary

Quasar Medical Singapore is seeking a QC Inspector to support quality activities in Singapore Operations, including new product development and transfers.

You will assist with incoming, in-process and final inspections, collaborate with QA engineers, and help maintain calibration and validation protocols in a cleanroom environment. Strong communication and GMP knowledge are essential.

Qualifications

• GCE O level or equivalent; Diploma preferred; 1–2 years quality responsibility.
• Excellent communication skills; English written and oral.
• Computer literate (MS Office).
• Knowledge of GMP requirements.
• FDA regulations and ISO 13485 knowledge is a plus.
• Willing to work in a multi-cultural team and clean room environment.

Responsibilities

• Support the implementation of standards and procedures for incoming inspection, WIP, final/ outgoing inspection & lot release.
• Perform receiving inspection for raw materials and in-process/ outgoing inspection/ lot release.
• Assist QA engineer in investigating quality issues.
• Assist calibration/ preventive maintenance systems.
• Assist qualification/ validation processes and protocol development.
• Review and approve quality records including inspection reports and lot history.
• Perform testing and reporting of quality and reliability data.
• Participate in NCMR process for non-conforming products.
• Maintain compliance with ISO13485, GMP and CFR Part 820 regulations.

Skills

Excellent communication

MS Office

GMP procedure literacy

FDA/ISO13485 knowledge (nice to have)

Education

GCE O level or equivalent

Diploma preferred

Job description

Quasar Medical Singapore is seeking a QC Inspector to support quality activities in Singapore Operations, including new product development and transfers.

You will assist with incoming, in-process and final inspections, collaborate with QA engineers, and help maintain calibration and validation protocols in a cleanroom environment. Strong communication and GMP knowledge are essential.