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Regulatory Affairs / Quality Assurance Engineer

Regulatory Affairs / Quality Assurance Engineer

Genadyne BiotechnologiesHicksville, NY, US
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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
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    Regulatory Engineer • Hicksville, NY, US

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