Associate Manager, Quality Assurance


HireMinds is excited to partner with this mission-driven company developing cutting-edge technologies and infrastructure to cure fatal organ diseases!


We need your expertise in quality assurance and compliance to support regulatory and clinical efforts to reach FDA approval of our tissue engineered products.


Responsibilities include but are not limited to the following:


  • Lead the QA team in support of efforts to reach FDA approval of tissue engineered products

  • Responsible for managing deviations, failure investigations, change control, complaints, SOP, product quality review

  • Write and update SOPs

  • Review documentation for accuracy, completeness, and compliance with our policies and GMP/QSR/Clinical trial requirements

  • Perform internal and vendor audits

  • Perform raw material review, inspection, release

  • Lead controlled document review and approval

  • Support FDA and regulatory inspections and mitigate potential issues

  • Assist other departments to support validation protocols and reports




  • Bachelor’s degree in science or engineering

  • 6+ years’ experience in a GMP/QSR regulated environment

  • 6+ years’ experience tissue banking or cell processing

  • Experience in review and audit of medical and quality records

  • TrackWise and MasterControl experience

    Contact us today for full job description and more details!