QA & QC Manager -Bilingual (Korean/English)

  • Santa Fe Springs, CA, USA
  • 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.

Job Description

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)

Qualifications

  • 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


 

Additional Information

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