Lead V&V QA Engineer - MedTech

Capgemini • Burlington, MA

8d • $82,082 - $164,164 • Remote

About The Position

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same. We’re looking for a collaborative and detail-oriented Software Quality Lead to ensure end-to-end software quality across the development lifecycle for systems supporting IDE clinical investigations and PMA submissions. Reporting to the Head of Quality, you will lead software quality governance, strengthen compliance with FDA requirements, and continuously improve processes to support safe, effective products.

Requirements

• 10+ years of experience in software quality within regulated environments (medical device experience preferred)
• Experience supporting IDE, PMA, or similar regulatory pathways, including clinical evidence requirements
• Strong knowledge of SDLC and design controls (e.g., traceability, DHF)
• Demonstrated ability to evaluate and improve SOPs and quality systems
• Experience with risk-based software verification and validation aligned with FDA expectations
• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)
• Proficiency with test management, defect tracking, and quality documentation tools
• Strong analytical, communication, and stakeholder engagement skills

Responsibilities

• Lead software quality governance across the SDLC, ensuring readiness from requirements through verification/validation and release
• Review and improve SOPs and quality processes to address gaps, inconsistencies, and regulatory alignment
• Ensure full traceability across user needs, requirements, risk controls, and V&V activities
• Oversee design controls and ensure Design History File (DHF) deliverables are complete and audit-ready
• Support IDE clinical study readiness, including configuration management, version control, and change impact assessments
• Guide risk-based software V&V activities, ensuring validation evidence is clear, complete, and defensible
• Collaborate cross-functionally with software, systems, and regulatory teams to define and meet quality expectations
• Support PMA submissions, audits, and regulatory interactions with documentation and subject matter expertise

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed