QC Inspector

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.