Staff SW QA Engineer
$116,600–$194,400 year
RemoteUnited States
Job Summary
Lead technical expertise for software quality assurance activities, including risk management following ISO 14971. Support scalable quality systems, risk practices, and compliance strategies ensuring product safety and regulatory adherence. Partner with senior R&D, quality, regulatory, clinical, cybersecurity, and business leaders to drive continuous SDLC improvements. Provide technical oversight for software risk management, DFMEA, PFMEA, and hazard analysis. Review and approve critical quality deliverables, including design history files and V&V protocols. Drive organizational improvements in verification, validation, and compliance processes while mentoring cross-functional teams. Evaluate emerging regulations and define quality strategies supporting business objectives.
Required Qualifications
- extensive medical device experience
- demonstrated expertise in FDA 21 CFR Part 820
- IEC 62304
- ISO 13485
- ISO 14971
- IEC 82304
- EU MDR
- applicable global regulatory requirements
- advanced knowledge of software development lifecycle processes
- software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation
- deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities
- advanced understanding of software risk management principles, methodologies, and regulatory expectations
- demonstrated ability to influence organizational direction and lead cross-functional initiatives without direct authority
- strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms
- experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors
- exceptional written, verbal, and executive-level communication skills
- the ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion
- demonstrated success mentoring engineers and developing organizational quality capabilities
- Bachelor's Degree in a technical discipline
- minimum of 8-12 years related experience
- Master's degree and 5-7 years equivalent industry experience
- PhD and 2-4 years of experience
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