Regulatory Affairs/Quality Assurance Engineer
Company: Genadyne Biotechnologies
Location: Hicksville
Posted on: December 30, 2025
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Job Description:
Job Description Job Description 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 Powered by JazzHR oSPuR7OKHc
Keywords: Genadyne Biotechnologies, Passaic , Regulatory Affairs/Quality Assurance Engineer, Engineering , Hicksville, New Jersey
