QC Inspector

10 hours ago

Sembawang, Singapore Quasar Medical (Singapore) Pte Ltd Full time $40,000 - $60,000 per year
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.

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