Quality Assurance Software Engineer

2 weeks ago

Santa Clarita, California, United States huMannity Medtec Full time

At HuMannity Medtec, we are at the forefront of developing transformative medical technologies that address critical healthcare challenges. Our team comprises engineers, scientists, and medical device professionals dedicated to crafting innovative solutions for the future. We offer a supportive and dynamic work environment that values diversity and excellence.

We prioritize work-life balance and provide a unique 9/80 work schedule, allowing for every other Friday off, resulting in 26 long weekends each year.

We are seeking a skilled and driven Software Validation Quality Engineer to enhance our Quality Assurance team. This role is crucial for refining processes, boosting efficiency, and upholding our ISO 13485 certification.

Position Overview:

The Software Validation Quality Engineer (SVQE) will oversee system and software validation tasks for electronic computer systems, including conducting risk management activities related to quality system software.

Key Responsibilities:

  • Identify software requiring qualification, verification, or validation, including electronic systems, commercial software, and system software.
  • Support all company initiatives as directed by management in alignment with Quality Management Systems (QMS).
  • Implement and uphold software quality engineering practices while providing quality engineering assistance for software.
  • Ensure software systems are developed, validated, and maintained in accordance with regulatory standards and business requirements.
  • Offer guidance and support to R&D engineers regarding Software Validation, Data Integrity, and Software Requirement Specifications.
  • Collaborate with R&D, Quality Engineering, and Manufacturing Engineering to fulfill system/software requirements and other verification and validation activities.
  • Engage in reviews of System and Software requirements, interpreting and assessing system design (hardware, firmware, software) to provide constructive feedback.
  • Create and execute or oversee software validation protocols that are traceable to system/software requirements.
  • Ensure timely completion of Software Validation Quality Engineering deliverables, including test plans (both manual and automated), test scripts, and test reports.
  • Utilize testing equipment and instrumentation to gather test data from devices and analyze the results effectively.
  • Participate in the design, coding, testing, debugging, and configuration of computer software.
  • Employ systematic problem-solving techniques to identify, prioritize, communicate, and resolve issues.
  • Adhere to U.S. Food and Drug Administration (FDA) regulations, other regulatory standards, company policies, operating procedures, and assigned tasks.

Qualifications:

  • Bachelor's degree with 3-5+ years of relevant experience in the medical device sector.
  • Experience with ISO 13485:2016 and IEC 62304 is essential.
  • Familiarity with FDA's General Principles of Software Validation Guidance is required.
  • Knowledge of standards such as GAMP5 is beneficial.
  • Understanding of risk management principles for the medical device industry (ISO 14971) is necessary.
  • Experience with Software Quality management tools is preferred.
  • Familiarity with Mobile Test Automation is an advantage.

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