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SR Quality Engineer

4 months ago

Neptune City, United States Medix Full time

Job Summary:

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.

Primary Responsibilities:

  • Develop and implement methods for process control, validation, improvement, testing, and inspection.
  • Design experiments to identify sources of variation and use statistical methods for analysis.
  • Conduct product testing and analysis to maintain quality levels and reduce defects.
  • Collaborate with suppliers to address quality issues and lead supplier qualifications.
  • Ensure corrective actions are implemented (CAPA, SCAR)
  • Provide Quality expertise in Product Development, Design Control, Risk Management, and CE Technical Files.
  • Create and maintain product documentation in compliance with regulations.
  • Coordinate product testing with internal and external labs.
  • Ensure compliance with domestic and international regulations.
  • Lead investigations of non-conformance and develop corrective actions.

Education:

Bachelor's degree in Engineering, Science, Math, or a related technical field.

Work Experience:

Minimum of 2 years of experience in Quality or Engineering in Medical Devices, drugs, or related fields.