Senior Software QAE

CoreTechs

Charlottesville, VA

$112–$136 Per Year
Instant Apply

8 days ago

Job Description

Senior Software Quality Assurance Engineer – Medical Devices
Charlottesville, VA

On-site Role – Relocation Assistance Available

Help ensure the safety, security, quality, and compliance of software-based medical devices throughout the product lifecycle.

We’re seeking an experienced Senior Software Quality Assurance Engineer to provide independent Quality oversight and advanced technical guidance for the development, validation, release, and post-market maintenance of software-based medical devices.

This role independently leads complex Software Quality activities within established Quality System and software lifecycle frameworks, including the review of software requirements, testing strategies, cybersecurity controls, and validation, while supporting continuous improvement.

You’ll partner closely with Software Development, Product Development, Regulatory Affairs, Manufacturing, and Product Management to ensure products are safe, effective, secure, and compliant with applicable regulatory and Quality requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES:
This position provides leadership and Quality oversight across:

Software Quality & Design Control Oversight
Technical Software Review
Verification & Validation
Software Risk Management
Cybersecurity Quality Oversight
Quality System & Compliance
Supplier Quality & Third-Party Software Oversight

EDUCATION & EXPERIENCE:

Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related technical discipline
Minimum 5 years of progressive experience in Software Quality Assurance, Software Engineering, Software Validation, or Software Quality Engineering within a regulated industry, including demonstrated experience independently leading complex Software Quality activities in a regulated environment
Hands-on software development experience with the ability to independently evaluate software engineering deliverables
Experience with one or more programming languages, including C++, and embedded software development
Ability to assess software development best practices
Understanding of software build and release processes
Knowledge of APIs, cloud services, and system integrations
Experience with Azure DevOps, GitHub, GitLab, Jira, Jama, automated testing frameworks, and Continuous Integration/Continuous Deployment (CI/CD) environments

REGULATORY & QUALITY KNOWLEDGE:
Working knowledge of:

FDA 21 CFR Part 820
FDA Design Controls
FDA Software Validation Guidance
FDA Cybersecurity Guidance
ISO 13485
ISO 14971
IEC 62304
IEC 60601
IEC 81001-5-1
ISO/IEC 27001
EU MDR
MDSAP requirements
Applicable global medical device regulations and standards

PREFERRED QUALIFICATIONS:

Medical device industry experience
Experience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), embedded software, connected medical devices, mobile applications, cloud-based software platforms, and/or AI-enabled technologies
Ability to read and understand source code and experience participating in code reviews
Understanding of software architecture and design patterns
Experience participating in regulatory inspections and Quality System audits
ASQ Certified Software Quality Engineer (CSQE)
ISTQB Software Testing Certification
Certified Secure Software Lifecycle Professional (CSSLP)
Certified Information Systems Security Professional (CISSP)
ISO/IEC 27001 Internal Auditor or Lead Auditor

READY TO MAKE AN IMPACT?

If you bring strong Software Quality expertise, hands-on software development knowledge, and experience working in a highly regulated environment, we’d like to hear from you.

Apply today to help advance the quality, safety, security, and compliance of next-generation medical device software.

We are an equal opportunity employer, and we are an organization that values diversity. We welcome applications from all qualified candidates, including minorities and persons with disabilities.

req26-00568

Numbers & Facts

Location	Charlottesville, VA
Salary	$112–$136 Per Year

Skills

American Society for Quality (ASQ)unmatched
Application Programming Interface (API)unmatched
Artificial Intelligence (AI)unmatched
Atlassian JIRAunmatched
Auditingunmatched
Best Practicesunmatched
Biomedical Engineeringunmatched
Build Managementunmatched
C++ Programming Languageunmatched
CISSP - Certified Information Systems Security Professionalunmatched
Cloud Applicationsunmatched
Cloud Computingunmatched
Code Reviewsunmatched
Code of Federal Regulationsunmatched
Computer Engineeringunmatched
Computer Scienceunmatched
Continuous Deployment/Deliveryunmatched
Continuous Improvementunmatched
Continuous Integrationunmatched
Design Patterns Programming Methodologiesunmatched
DevOpsunmatched
Diversityunmatched
Electrical Engineeringunmatched
Embedded Softwareunmatched
FDA (Food and Drug Administration)unmatched
GitHubunmatched
Healthcare Softwareunmatched
ISO (International Organization for Standardization)unmatched
ISTQB Foundationunmatched
Information Technology/Systems Auditunmatched
Internal Auditunmatched
International Electro-Technical Commission (IEC)unmatched
Internet Securityunmatched
Manufacturing Managementunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Microsoft Windows Azureunmatched
Mobile Applicationsunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Managementunmatched
Programming Languagesunmatched
Quality Assuranceunmatched
Quality Assurance Softwareunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Regulationsunmatched
Release Management/Engineeringunmatched
Risk Managementunmatched
Safety/Work Safetyunmatched
Software Administrationunmatched
Software Architecture Designunmatched
Software Designunmatched
Software Developmentunmatched
Software Development Lifecycle (SDLC)unmatched
Software Engineeringunmatched
Software Evaluationunmatched
Software Testingunmatched
Software Validationunmatched
System Integration (SI)unmatched
System Lifecycleunmatched
Technical Leadershipunmatched
Test Harnessunmatched
Test Requirementsunmatched
Test Strategyunmatched
Validation Testingunmatched

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