QA Engineer
Ambush
AndroidiOSJenkinsSelenium
Software Quality Engineer
Prenosis
full-time
Posted on:
Location Type: Remote
Location: Remote • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $80,000 - $100,000 per year
Job Level
Mid-LevelSenior
Tech Stack
AWSAzureCloudCyber SecurityGoogle Cloud Platform
About the role
- Execute quality assurance activities for all product development activities.
- Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements.
- Partner with cross-functional teams, including marketing, R&D, clinical, and regulatory to deliver quality, compliant products.
- Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
- Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards.
- Engage in design and development activities for both medical and non-medical software.
- Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability.
Requirements
- Bachelor’s degree in Computer Engineering, Software Engineering, or Computer Science.
- Minimum of 3 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Systems Engineering.
- Experience with regulatory agencies and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD).
- Experience working through software lifecycle processes (Agile SAFe/Waterfall).
- Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
- Experience working with cloud-based platforms (e.g., AWS, Azure, GCP)
Benefits
- Comprehensive Medical, dental, and vision coverage
- 401(k) with company match
- Unlimited PTO
- Major opportunity for career development to make significant impact at an exciting growth-stage company
- Collaborative and innovative work environment
- Chance to make a real impact on patient care
- Opportunity to work on cutting-edge AI technology in healthcare
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assurancesoftware designsoftware developmentrisk managementISO14971continuous improvementsoftware lifecycle processessFMEAsoftware testingverification/validation
Soft skills
collaborationcommunicationleadership
