SR Quality Engineer- **

  • Neptune
  • Medix™
Job Summary:<br><br>This role sets quality standards for in-process activities and leads testing method development, sampling, and training. Responsibilities include process evaluation, improvement suggestions, vendor management, and maintaining regulatory compliance.<br><br>Primary Responsibilities:<br><ul><li>Develop and implement methods for process control, validation, improvement, testing, and inspection.</li><li>Design experiments to identify sources of variation and use statistical methods for analysis.</li><li>Conduct product testing and analysis to maintain quality levels and reduce defects.</li><li>Collaborate with suppliers to address quality issues and lead supplier qualifications.</li><li>Ensure corrective actions are implemented (CAPA, SCAR)</li><li>Provide Quality expertise in Product Development, Design Control, Risk Management, and CE Technical Files.</li><li>Create and maintain product documentation in compliance with regulations.</li><li>Coordinate product testing with internal and external labs.</li><li>Ensure compliance with domestic and international regulations.</li><li>Lead investigations of non-conformance and develop corrective actions.</li></ul><br>Education:<br><br>Bachelor's degree in Engineering, Science, Math, or a related technical field.<br><br>Work Experience:<br><br>Minimum of 2 years of experience in Quality or Engineering in Medical Devices, drugs, or related fields.