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 higher, Diploma preferred, with 1~2 years of progressive Quality responsibility preferably in Medical Device 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 ISO 9001, ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives.
- Willing to work in a multi-cultural team and in a clean room environment.
