Regulatory Affairs​/Quality Assurance Engineer

Regulatory Affairs/Quality Assurance Engineer Overview

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.

• 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.
• Maintain 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 effective test methods.
• Facilitate software design and development for medical devices.
• Performance testing and reporting on software, hardware and the compatibility for all accessories.
• Perform risk assessments for medical devices and accessories.
• Development and prototyping of new products with existing or new vendors.

• Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field. (Master degree preferred.)
• Familiar with FDA CFR 820, ISO 134850, SOPs regulations.
• Extreme attention to details.
• Ability to think outside the box with excellent problem solving abilities.
• Excellent interpersonal, communication, and writing skills.
• Highly organized.
• Excellent computational skills.
• Knowledge of European regulations is a plus.
• Knowledge of common medical materials (silicone, polyurethane, etc.).
• Knowledge of electrical circuits and basic programming.
• Knowledge of C/C++ is a plus.
• Maintain MDD/MDR EN ISO

• Regulatory compliance.
• Quality management.
• Cross functional team management.
• Quality assurance.

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

$68,000 - $72,000/Annual

Brooklyn, NY