Inspector, QC

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

Our Culture

We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need.

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

• 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.

Authority

• NA

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.

Work Environment

• Controlled Environment (Class 10K/100K cleanroom) and office area.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference. Check out our open positions and bring your passion to life.

True To Quality

At Quasar, quality is more than just a priority - it is part of our culture. Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life-giving therapies for patients all over the world, and we take this responsibility seriously. Explore exciting career opportunities with Quasar by browsing our current job openings. We look forward to hearing from you!

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally. What we make saves lives. If you share our commitment to quality and innovation, we want to hear from you.