Genadyne Biotechnologies, Inc. · 3 months ago
Regulatory Affairs/Quality Assurance Engineer
Hicksville, NY
Full-time
Onsite
Entry, Mid Level
$68K/yr - $72K/yrGenadyne Biotechnologies is seeking a motivated and intelligent Regulatory Affairs/Quality Assurance Engineer to develop and maintain quality and regulatory compliance in their processes. The individual will ensure compliance with ISO 13485 and MDSAP requirements, while also managing various quality assurance responsibilities.
BiotechnologyHealth CareTelecommunicationsTelehealth
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
Qualification
Required
Develop and maintain quality and regulatory compliance in Genadynes' processes
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
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
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
Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field
Preferred
Master degree preferred
Knowledge of C/C++ is a plus
Benefits
Medical
Dental
Vision
PTO
401K
Legal Services
FSA
Life Insurance
Company
Genadyne Biotechnologies, Inc.
Genadyne Biotechnologies Inc.
Founded in 1999
51-200 employees
H1B Sponsorship
Genadyne Biotechnologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2022 (5)
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Shahzad Pirzada
Business Owner
Recent News
2025-04-04
2023-12-23
2023-12-23
Company data provided by crunchbase