Software Quality Engineer for Medical Devices
2 weeks ago
US Tech Solutions is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring the highest standards of quality are met throughout the software development lifecycle.
About the Job:
- Develop and implement quality assurance strategies to ensure compliance with regulatory requirements and industry standards.
- Evaluate and improve existing processes and procedures to increase efficiency and effectiveness.
- Collaborate with cross-functional teams to identify and mitigate risks, and develop mitigation plans.
- Provide training and education to team members on quality assurance principles and best practices.
Requirements:
- Proven experience in software development for medical devices, specifically focusing on SaMD 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.
- Demonstrated ability to effectively use a variety of tools required for product development and communication, including Google Suite.
Salary and Benefits:
- Estimated salary: $110,000 - $150,000 per year.
- Ongoing training and education opportunities.
- Opportunity to work with a global staff augmentation firm providing talent on-demand and total workforce solutions.
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