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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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