Sr. Software Quality Assurance Engineer

MicroAire Surgical Instruments LLC As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway— you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. The Senior Software Quality Assurance Engineer provides independent Quality oversight and advanced technical guidance for the development, validation, release, and post-market maintenance of software-based medical devices throughout the product lifecycle. This role independently leads complex software Quality activities within established quality system and software lifecycle frameworks such as reviewing software requirements, testing strategies, cybersecurity controls and validation; while supporting continuous improvement. This role partners 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. Love finding the question no one has asked yet? At MicroAire, software quality is about more than checking a box. It helps ensure the medical devices clinicians rely on are safe, effective, and secure. We’re looking for a Senior Software Quality Assurance Engineer who can dig into complex software, spot risks early, and work with engineers to find practical solutions. You’ll lead software quality activities across development, testing, release, and ongoing product support, partnering with teams across Engineering, Regulatory, Product, and Manufacturing. If you enjoy connecting the technical details to the people who depend on the product, bring your curiosity and sound judgment to a team where your work matters. + Essential Duties and Responsibilities

Software Quality and Design Control Oversight

• Provide Quality Assurance oversight for software development activities throughout the product lifecycle.
• Ensure compliance with Design Control and Software Lifecycle requirements.
• Author, review, and approve software development documentation within delegated authority and in accordance with established procedures, including:
• User Needs
• Design Inputs and Requirements
• Software Design Specifications
• Verification and Validation Protocols
• Test Reports
• Traceability Matrices
• Release Documentation
• Risk Management Documentation
• Participate in design reviews, software development reviews, risk reviews, and release reviews.
• Ensure software development processes comply with internal Quality Management System (QMS) requirements.

Technical Software Review

• Review software technical documentation and development practices for compliance with Quality and regulatory requirements.
• Participate in technical evaluation of source-code or code-review evidence, as applicable.
• Evaluate software design and technical risk assessments.
• Assess software change requests and their impact on product Quality, risk, and regulatory compliance.
• Support investigations of software defects and field issues through technical review and root cause analysis.
• Collaborate with engineering teams to drive continuous improvement in software Quality and development practices.

Verification and Validation

• Leads the development and execution of product or project level software verification and validation strategies within established lifecyle and Quality frameworks.
• Ensure testing is performed, documented, and reviewed at appropriate levels, including:
• Unit Testing
• Integration Testing
• System Testing
• Regression Testing
• Automated Testing
• User Acceptance Testing
• Verify traceability between requirements, risks, design outputs, and testing activities.
• Evaluate test coverage, unresolved defects, and release readiness.

Risk Management

• Support software risk management activities in accordance with applicable standards and regulations.
• Participate in:
• Hazard Analyses
• Failure Modes and Effects Analyses (FMEA)
• Cybersecurity Risk Assessments
• Benefit-Risk Evaluations
• Ensure software-related risks are identified, controlled, verified, and documented.

Cybersecurity Quality Oversight

• Provide Quality oversight for secure software development lifecycle activities.
• Review cybersecurity documentation, including:
• Threat Models
• Security Requirements
• Vulnerability Assessments
• Penetration Testing Reports
• Security Risk Assessments
• Software Bills of Materials (SBOMs)
• Support implementation and maintenance of cybersecurity processes consistent with IEC 81001-5-1.
• Collaborate with Cybersecurity and IT teams to ensure alignment with organizational information security controls and ISO/IEC 27001 principles.
• Support post-market cybersecurity monitoring, vulnerability management, and security update processes.

Quality System and Compliance

• Ensure compliance with applicable global regulatory and Quality requirements.
• Support internal audits, supplier audits, notified body audits, MDSAP audits, and regulatory inspections.
• Review software-related nonconformances, deviations, CAPAs, and complaint investigations.
• Support Management Review activities and software Quality metric reporting.
• Lead and implement continuous improvement initiatives within the software Quality system.

Supplier Quality and Third-party Software Oversight

• Support qualification and oversight of software suppliers and development partners.
• Review supplier Quality documentation and audit results.
• Assess risks associated with third-party software components, open-source software, and cloud service providers.
• Support supplier corrective action activities as required. + Education and Experience
• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related technical discipline.
• Minimum of five (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
• 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. 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 Audito