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Senior Quality Engineer

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Reference Number: CG-4265284975
Date Posted: 10-25-22
Location: Northeast

Our client is a specialty medical device company. They are seeking a Senior Quality Engineer to join their team in the Northeast.

What's in it for you...
  • Small to mid-sized company
  • Wear multiple hats
  • Company has a growth plan - acquisitions
To be considered for an interview, the following experience/skills are desired:
  • Bachelor’s degree in Microbiology, Biology, Biomedical Engineering, or equivalent field
  • 2-6+ years of equivalent experience in a related field
  • Functional understanding of medical device standards ISO 13485, ISO 11138-7, and ISO 14971
  • Experience reading and interpret standards in the areas sterilization, bioburden, endotoxins, relevant product testing, and environmental monitoring for development and modification of procedures and protocols
  • Experience with environmental monitoring and ensuring compliance to applicable standards and company procedures
  • Experience understanding & executing risk management practices in relation to environmental monitoring and bioburden and relevant excursion
  • Experience supporting root cause determinations and execution of corrective actions per NCMR’s and CAPA’s
If you experience technical difficulties when applying to this position, please email your resume directly to MedicalDeviceTeam@MRIGlobalMedDevice.com