Embedded Systems Quality Assurance Specialist

2 weeks ago


Buffalo, New York, United States DeBellis Catherine & Morreale - Corporate Staffing Full time

Overview: DeBellis Catherine & Morreale - Corporate Staffing is seeking a skilled Quality Assurance Engineer with a robust background in embedded Linux systems and medical device software compliance. This pivotal role is essential for ensuring that our innovative medical devices adhere to rigorous industry standards and regulatory frameworks.

Key Responsibilities:

  • Manage the complete lifecycle of bug tracking and feature enhancements, ensuring that all modifications are thoroughly documented and linked to specific requirements.
  • Collaborate with development teams to conduct in-depth investigations, implement accurate fixes, and perform comprehensive testing of software issues.
  • Develop, execute, and document detailed test plans for the validation and verification of software functionalities, ensuring alignment with FDA 510(k) requirements.
  • Establish and maintain CI/CD pipelines to automate testing processes, enhancing the efficiency of the development lifecycle.
  • Engage in the formulation and assessment of system requirements to guarantee testability and traceability in accordance with medical device regulations.
  • Offer technical guidance and support to team members regarding best practices in software quality assurance.
  • Stay informed about regulatory standards impacting software quality assurance in the medical device sector, including:

FDA's 21 CFR Part 820 for quality system regulations

IEC 62304 for medical device software lifecycle processes

ISO 13485 for medical device quality management systems

ISO 14971 for risk management

Qualifications:

  • Bachelor's degree in Computer Science, Electrical Engineering, or a related field, or equivalent experience.
  • A minimum of 3 years of experience in QA for embedded systems, ideally within the medical device industry.
  • Proficient programming skills in C and Python.
  • Extensive knowledge of Linux operating systems and kernel-level testing.
  • Experience with CI/CD tools and methodologies.
  • Familiarity with regulatory standards and documentation requirements specific to class 2 medical devices and 510(k) submissions.
  • Strong analytical, problem-solving, and communication abilities.

Preferred Qualifications:

  • Experience with i.MX7 processor, STM32, AVR, or similar hardware.
  • Certification in Quality Assurance or Software Testing.

Note: Candidates must currently reside in the Buffalo/Rochester, NY area. Relocation assistance is not available.



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