Associate Engineer I Quality
Alajuela, Costa Rica
hace 3 días

Job Description

Leads multiple quality assurance projects and activities to support the sterility and pyrogenicity requirements of medical products. Job duties :

  • Manages microbiological testing performed in-house and by outside laboratories.
  • Works with new product validation for steam, heat, radiation, and ethylene oxide sterilization.
  • Coordinates cleanroom microbial and particulate testing.
  • Coordinates pyrogen testing validation.
  • Coordinates Bioburden and Sterility test.
  • Coordinates Compressed Air annual validation.
  • Coordinates Requalification of the Action / Alert Levels.
  • Performs other duties or responsibilities as assigned.
  • Qualifications

  • Bachelor’s Degree in related field or equivalent; advanced degree a plus.
  • Minimum of seven (7) years of related experience.
  • Good communication skills.
  • Past leadership or supervisory experience.
  • Desired Qualifications

  • Excellent command of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring.
  • Working knowledge of various sterilization processes including steam, heat, radiation, and ethylene oxide.
  • Working knowledge of sterilization and pyrogen testing, microorganism identification and skill performing sterilization product release testing on biological indicators.
  • Experience with parametric release validations and requirements.
  • Skill determining root causes of unanticipated high microbial or pyrogen levels on products.
  • Expertise setting up a microbiology testing laboratory with the ability to specify and procure equipment and supplies for in-house sterility testing.
  • Good command of appropriate laboratory practices.
  • Successful track record training and supervising staff performing microbiological testing.
  • Past experience participating in audits to assure compliance with FDA, ISO and other requirements.
  • Outside US

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