US_East | QA​/Quality Engineer_L

Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential

TMR : J7

TQQH

Role:
Senior Software Quality Assurance Engineer

Work location:

Andover, MA

Background and Meet and Greet: MANDATORY

As a Senior Software Quality Assurance Lead – IDE & PMA (SDLC Governance) for our medical device manufacturer client 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.

• Owning software quality governance across the SDLC, ensuring readiness from requirements through V&V and release for IDE and PMA
• Reviewing and challenging existing SOPs and quality processes to identify gaps, inconsistencies, or misalignment with regulatory expectations
• Ensuring end to end traceability across user needs, requirements, risk controls, and verification/validation activities
• Governing software design controls and ensuring completeness and audit readiness of DHF deliverables
• Supporting IDE clinical study readiness including configuration management, version control, and change impact assessments
• Overseeing risk based software V&V activities and ensuring validation evidence is complete and defensible for regulatory submissions
• Collaborating cross functionally (software, systems, regulatory) to ensure quality requirements are defined and met
• Supporting PMA submissions, audits, and FDA interactions by providing software quality documentation and SMEs support

• 10+ years of experience in software quality assurance within regulated environments (medical device 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 (e.g., traceability, DHF)
• 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 (e.g., 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