Quality Assurance Specialist

Quality Assurance Specialist to provides support to complaint product return, investigation, and resolutions and conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes.

Responsibilities:

• Completes compliant documentation and provides solutions to local problems of low scope and complexity.
  
• Supports project work and acts as community member.
  
• Quality System Compliance: Maintains awareness of industry regulatory standards.
  
• Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to the department manager.
  
• Applies basic Risk Management principles to work.
  
• Review complaints.
  
• Generate exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine issues.
  
• Investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions.
  
• Utilize data and quality policies as necessary to support investigations.
  
• Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.
  
• Work with other affiliates and regional groups as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations.
  
• Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
  
  

Requirements

• Bachelor s Degree in Engineering or Science with major in Electrical, Mechanical, Computer Science, Chemical, or any field of life science.
  
• Minimum of 3 years of relevant experience in a regulated environment (preferable FDA regulated industry).
  
• ISO 13485, FDA 21 CFR 820, and Lean Six Sigma Green Belt certification highly desirable.
  
• ASQ Certifications are a plus
  
• Bilingual (English & Spanish)
  
• MS Programs
  
• Training Compliance