Medical Devices Software Quality Assurance Specialist

2 days ago


San Bruno, California, United States US Tech Solutions Full time
Job Title: Medical Devices Software Quality Assurance Specialist

The client is leveraging a data-driven approach to revolutionize health management and healthcare delivery. As a champion of Quality Assurance, you will ensure adherence to high standards and corporate requirements throughout the software development lifecycle.

Key Responsibilities:

  • Act as a Quality Assurance champion, ensuring adherence to high standards and corporate requirements.
  • Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry.
  • Support the creation and maintenance of Design History Files (DHF), including development plans, verification and validation plans, requirements specifications, and risk management files.
  • Integrate ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
  • Provide ongoing training and education on quality systems and SDLC frameworks, and support CAPA, complaints, audits, and overall QMS functions.

Requirements:

  • Proven experience in software development for medical devices, specifically focusing on Software as a Medical Device (SClient) or low-risk enforcement discretion products.
  • At least 3-5 years of recent experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304.
  • Hands-on experience in Software Quality Engineering (QE) rather than hardware or test engineering.
  • Proficiency in applying quality principles throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485.
  • Experience with diverse tools for quality assurance and engineering tasks, showing adaptability to different environments.
  • Agile and Microservices Experience: Experience working in an agile development environment, particularly with microservice-based architectures.

Preferred Skills:

  • QMS
  • SClient
  • Agile, Scrum or Waterfall
  • Microservices
  • Risk Management
  • DHF

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



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