Lead V&V QA Engineer - MedTech

About the role you're considering

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.

Your role

• 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

Your skills and experience

• 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

The base compensation range for this role in the posted location is: $82,082 - $164,164

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include: • 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