Quality Assurance Specialist- Sterilization/Sterilization Quality Engineer

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices.  This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

  • Support validation of sterilization processes in accordance with industry standards
  • Manage validation of upgrades to clean rooms and administer an effective environmental monitoring program
  • Support sterile barrier packaging validations.
  • Implement and maintain quality system processes in accordance with applicable regulatory requirements.
  • Review manufacturing quality records in support of lot release
  • Participate in compliance activities e.g., complaints, corrective actions, non-conformances.
  • Maintain Microbiology/sterilization procedures for continuous improvement as required by the quality system

Other duties as assigned

EXPERIENCE/SKILL REQUIREMENTS:   

2-5 years of experience in QA.  A working knowledge in the following areas:

  • Experience with medical device product manufacturing in a Class 8 cleanroom
  • Experienced in quality systems such as ISO 13485, cGMP
  • Background in Quality/Assurance/Quality Control systems in a regulated environment
  • Experience in sterilization process management including validation
  • Experience validating and/or monitoring clean rooms
  • Comprehensive understanding of FDA regulations.
  • Experience with e-beam sterilization a plus

EDUCATIONAL REQUIREMENTS:  

Bachelor’s Degree in scientific field, preferred