QA Manager/Engineer

Job Responsibilities

1. Factory quality assurance representative, planning, setting and achieving annual quality goals.
2. Performance management and assessment of quality control and quality assurance personnel.
3. Establish and maintain relevant quality system documents at the factory.
4. Review the compliance of DMR/DHR, and the correctness of CoC and related reports to ensure that product quality meets customer and regulatory requirements.
5. Management and improvement of IQC/IPQC/FQC/OQC and product-related testing.
6. Supervise the analysis and improvement results of abnormal events, and investigate the causes and countermeasures of internal and external quality problems.
7. Lead the implementation and effectiveness of factory correction prevention and customer complaint analysis and improvement measures.
8. Manage factory SQE process and team, and handle supplier quality incidents.
9. Coordinate the factory's response to audits by customers and competent authorities.
10. Coordinate across factories to establish and connect cooperation models with other units.
11. Plan quality-related training to enhance factory quality awareness.
12. Quality management of Process and Product.
13. Quality management of supplier.
14. New product introduction for mass production.
15. Execution of internal and external audit.
16. Plan and implement quality improvement system.
17. CAPA and nonconformity handling, review and monitor.

Requirements

1. Candidate must possess at least a Diploma/Bachelor's Degree in science/engineering/pharma/medical/biotechnology or equivalent.
2. Minimum 3 years’ relevant experience is preferred.
3. ISO 13485/FDA QSR system experience; CQT/CQE Six Sigma (black belt experience is a bonus).
4. Experience in new factory management.