Sr. Software Quality Assurance Engineer

Micro Aire 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 Micro Aire, 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.

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…