Job Information
Intellectt Inc. QUALITY ENGINEERS in Iselin, New Jersey
Develop and implement quality assurance protocols and procedures for rapid diagnostic kits, ensuring compliance with ISO 13485 and FDA regulations. Maintain accurate and detailed documentation of quality control activities, including test results, inspection records, and nonconformance reports. Utilize statistical analysis tools to monitor quality trends and identify areas for improvement. Develop key performance indicators (KPIs) and quality metrics to track and report on quality performance. Conduct risk assessments and failure mode and effects analysis (FMEA) to identify potential quality risks and develop mitigation strategies. Bachelor’s degree in Science, Technology or Engineering (any) is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S. Send Resume to HR Dept., Intellectt, Inc., 517 Route 1 South, Suite 2103, Iselin, NJ 08830.