QA & QC Manager -Bilingual (Korean/English) Details

QA & QC Manager -Bilingual (Korean/English)

Woongjin, Inc - Santa Fe Springs, CA

Employment Type : Full-Time

Company Description

Our Mission

WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership.

In this role, the QC & QA Manager is responsible for standardizing complaint handling infrastructure, standardizing all SOP related medical device handling and responsible for AATB and Tissue Bank licensing is up to date.

• Draft quality assurance policies and procedures
• Interpret and implement quality assurance standards and procedures
• Evaluate adequacy of quality assurance standards
• Devise sampling procedures and directions for recording and reporting quality data
• Review the implementation and efficiency of quality and inspection systems
• Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
• Document internal audits and other quality assurance activities
• Investigate customer complaints and non-conformance issue
• Collect and compile statistical quality data
• Develop, recommend and monitor corrective and preventive actions
• Prepare reports to communicate outcomes of quality activities
• Identify training needs and organize training interventions to meet quality standards
• Coordinate and support on-site audits conducted by external providers
• Evaluate audit findings and implement appropriate corrective actions
• Monitor risk management activities
• Responsible for document management systems
• To create and maintain a product disposal system in accordance with AATB regulations
• To update and maintain complaint handling guideline with respect to product and adverse event complaints
• To establish a non-clinical sample use request and tracking system (Biologics)

• Able to multi-task and work independently
• Excellent written and verbal communication skills
• Able to manage time effectively
• Proficient in MS Office Suite
• Bilingual in Korean/English preferred
• Quality Control and Quality Affairs Managerial experience preferred
• Minimum 5-7 years of experience as Manager

All your information will be kept confidential according to EEO guidelines.