Quality Control Inspector - Medical Devices (Singapore)

Quasar Medical

Singapore

On-site

SGD 42,000 - 60,000

Full time

14 days+
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Qualifications

  • GCE O level or equivalent; Diploma preferred.
  • 1–2 years of progressive quality responsibility in Medical Device/Pharmaceutical manufacturing is desirable.
  • Strong communication skills in English, written and spoken, are essential.
  • Knowledge of GMP and quality standards (FDA/ISO 13485) is a plus.

Responsibilities

  • Support implementation of inspection standards for incoming materials, WIP, and final/product lot release.
  • Carry out receiving inspection for raw materials and in-process/outgoing inspections.
  • Assist quality engineer in investigations and calibration/maintenance systems.
  • Help qualify/validate processes and develop protocols with involved teams.
  • Review quality records and inspection reports; support non-conforming materials process.
  • Maintain compliance with ISO 13485, GMP and CFR Part 820 regulations.

Skills

Communication skills
English proficiency
MS Office
GMP/GxP knowledge
Quality systems

Education

GCE O level or equivalent
Diploma preferred

Tools

MS Office Suite

Job description

Inspector, QC page is loaded## Inspector, QClocations: Singapore, Singaporetime type: Full timeposted on: Posted 24 Days Agojob requisition id**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:- NAEducation/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**Check out our open positions and bring your passion to life.
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