Genadyne Biotechnologies

Genadyne Biotechnologies is seeking a motivated individual to develop and maintain quality and regulatory compliance processes. Responsibilities include ensuring compliance with ISO 13485 and MDSAP requirements, compiling audit documents, creating technical files, initiating corrective actions, and ensuring the effectiveness of quality control systems. The ideal candidate will also contribute to product development and risk assessment.

Requirements

• Ensure quality and processes are practiced and maintained.
• Compile documents for audits.
• Create and maintain product technical files.
• Initiate corrective and preventive actions for non-conformities.
• Maintain/calibrate testing equipment.
• Conduct risk assessments of medical devices and processes.
• Develop/design test methods.
• Facilitate software design and development for medical devices.
• Abilities: regulatory compliance, quality management, cross functional team management, quality assurance, software design and development, risk assessments, testing and reporting, software performance, electrical circuits and basic programming, C/C++ knowledge (plus).
• Understanding of European regulations is a plus.

Benefits

• Medical
• Dental
• Vision
• PTO
• 401K
• Legal Services
• FSA
• Life Insurance