Department: Regulatory

The Quality Associate will write or revise quality documentation, assist with raw material qualifications, perform in process and final quality inspections and lab testing.  Assist in conducting product extensions.  The Quality Associate works under general supervision or as part of a multifunctional team on assignments of varying degrees of complexity to ensure products and processes comply with the Company’s quality system and applicable regulatory requirements.


  • Bachelor of Science in clinical, biological, or chemical sciences
  • 4+ years of experience working in a clinical or medical device/IVD laboratory or an FDA regulated quality assurance medical device or pharmaceutical manufacturing environment
  • Ability to write technical reports and/or studies
  • Ability to analyze and present data in coherent and scientific manner
  • Excellent communications skills (both verbal and written)
  • Basic knowledge of Excel spreadsheets and statistics
  • Knowledge of ERP system
  • Detail oriented
  • Experience working under FDA/ISO regulations.


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