US_East | QA / Quality Engineer_L4

Senior Software Quality Assurance Engineer

As a Senior Software Quality Assurance Lead – IDE & PMA (SDLC Governance) for a medical device organization in the Greater Boston region, you will be responsible for ensuring end-to-end software quality across the development lifecycle for systems supporting IDE clinical investigations and PMA submissions. Working onsite and reporting to the Head of Quality, you will govern software quality practices, ensure compliance with FDA regulations, and proactively identify gaps or inconsistencies in existing SOPs.

• Own software quality governance across the SDLC, ensuring readiness from requirements through verification & validation (V&V) and release for IDE and PMA submissions

• Review and challenge existing SOPs and quality processes to identify gaps, inconsistencies, or misalignment with regulatory expectations

• Ensure end-to-end traceability across user needs, requirements, risk controls, and verification/validation activities

• Govern software design controls and ensure completeness and audit readiness of DHF deliverables

• Support IDE clinical study readiness including configuration management, version control, and change impact assessments

• Oversee risk-based software V&V activities and ensure validation evidence is complete, traceable, and defensible for regulatory submissions

• Collaborate cross-functionally (software, systems, regulatory) to ensure quality requirements are defined and met

• Support PMA submissions, audits, and FDA interactions by providing software quality documentation and SME support

• 10+ years of experience in software quality assurance within regulated environments (medical device industry preferred)

• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements

• Strong understanding of SDLC and design controls in regulated environments (traceability, DHF, etc.)

• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance

• Hands-on experience with software verification and validation using risk-based approaches aligned with FDA expectations

• Familiarity with FDA regulations and standards (21 CFR 820, 812, 814)

• Experience with test management, defect tracking, and quality documentation tools

• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran