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Regulatory Affairs/Quality Assurance Engineer

Company

Genadyne Biotechnologies

Location

Hicksville, New York

Type

Full-time

Position Description:



  • Seeking a motivated, intelligent and hard-working individual to Develop and maintain quality and regulatory compliance in Genadynes' processes.

Individual will ensure compliance with ISO 13485 and MDSAP requirements are maintained.   Specific Responsibilities :



  • Ensure the quality and processes are practiced and maintained.

  • Compile documents required for audits.
  • Create and maintain product technical files.
  • Initiate corrective and preventive actions for non-conformities.
  • Maintain/calibrate the accuracy of all testing equipment.
  • Conduct risk assessments of medical devices and processes.
  • Maintaining the effectiveness of quality control system and non-conforming materials control system.
  • Discuss and solve quality problems with vendors.
  • Investigate problems and make  improvement on current processes.
  • Develop/design effec...

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