Regulatory Affairs/Quality Assurance Engineer

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...