This listing was posted on The Resumator.
Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available
Location:
Hicksville, NY
Description:
Job description Regulatory Affairs/Quality Assurance Engineer - H1-B Sponsorship Available Position Description: Seeking a motivated, intelligent and hard-working individual to Develop and maintain quality and regulatory compliance in Genadyne' 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. Experiences: Regulatory compliance.Quality management.Cross functional team management.Quality assuranceFDA regulations: 1 year (Preferred) Requirements: Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field. (Master degree preferred.) Salary Range: $65,000 - 68,000/Annual Job Type: Full-time Benefits: Health Insurance Dental Insurance Vision Insurance Life Insurance Sick Time Off Vacation Time Off Schedule: 8 hour shift - In Person Monday - Friday (9:00 am - 5:30 pm) Powered by JazzHR
Company:
Genadyne Biotechnologies
Posted:
April 6 on The Resumator
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More About this Listing: Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available
Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available is a Quality Assurance QA Engineer Job at Genadyne Biotechnologies located in Hicksville NY. Find other listings like Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available by searching Oodle for Quality Assurance QA Engineer Jobs.
Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available is a Quality Assurance QA Engineer Job at Genadyne Biotechnologies located in Hicksville NY. Find other listings like Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available by searching Oodle for Quality Assurance QA Engineer Jobs.