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 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.

Abilities

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

Experiences

Regulatory compliance.

Quality management.

Cross functional team management.

Quality assurance

Requirements

Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field. (Master degree preferred.)

Benefits

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

Salary Range

$68,000 - $72,000/Annual