About The Position

Lead laboratory testing activities that support the quality and safety of reprocessed medical devices. Perform cleaning validation testing, including protein, hemoglobin, and TOC analysis to verify devices have been properly cleaned. Conduct materials testing using techniques such as FTIR and X-ray fluorescence. Perform water quality testing, including microbial, TOC, hardness, and chloride analysis. Prepare and inoculate products with simulated biological soils (blood, tissue, eggs, etc.) to support cleaning validation studies. Operate, maintain, calibrate, and troubleshoot laboratory equipment such as spectrophotometers, incubators, GC/MS systems, FTIR instruments, and X-ray fluorometers. Assist with developing, validating, and documenting laboratory test methods and analytical procedures. Analyze and interpret test results, ensuring accurate documentation and data integrity. Support regulatory inspections and audits by preparing data, explaining procedures, and demonstrating compliance. Ensure all laboratory work is conducted in accordance with cGMP, safety, quality, and regulatory requirements. Work independently and collaboratively to support manufacturing, quality, and compliance activities.

Requirements

  • High School Diploma/ GED
  • 5 Years of Related Experience
  • Experience working in a chemistry, analytical, quality control, quality assurance, medical device, pharmaceutical, biotechnology, or similar laboratory environment.
  • Familiarity with analytical testing methods and laboratory instrumentation.
  • Strong attention to detail and the ability to follow complex procedures and testing protocols.
  • Experience accurately documenting, reviewing, and reporting laboratory results.
  • Ability to make sound decisions based on established procedures and prior experience.
  • Comfortable handling hazardous biological materials, contaminated medical devices, and laboratory chemicals.
  • Strong organizational, communication, and teamwork skills.

Nice To Haves

  • Knowledge of cGMP, quality systems, and regulatory requirements is preferred.
  • Bachelor's degree in Chemistry, Biochemistry, Biology, or a related scientific field

Responsibilities

  • Lead laboratory testing activities that support the quality and safety of reprocessed medical devices.
  • Perform cleaning validation testing, including protein, hemoglobin, and TOC analysis to verify devices have been properly cleaned.
  • Conduct materials testing using techniques such as FTIR and X-ray fluorescence.
  • Perform water quality testing, including microbial, TOC, hardness, and chloride analysis.
  • Prepare and inoculate products with simulated biological soils (blood, tissue, eggs, etc.) to support cleaning validation studies.
  • Operate, maintain, calibrate, and troubleshoot laboratory equipment such as spectrophotometers, incubators, GC/MS systems, FTIR instruments, and X-ray fluorometers.
  • Assist with developing, validating, and documenting laboratory test methods and analytical procedures.
  • Analyze and interpret test results, ensuring accurate documentation and data integrity.
  • Support regulatory inspections and audits by preparing data, explaining procedures, and demonstrating compliance.
  • Ensure all laboratory work is conducted in accordance with cGMP, safety, quality, and regulatory requirements.
  • Work independently and collaboratively to support manufacturing, quality, and compliance activities.
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