Director of Quality Engineering

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Develop and oversee the comprehensive quality strategy for Software as a Medical Device (SaMD), AI/ML, and connected-device products.

• Assist in establishing the quality vision for web, mobile, backend, firmware/hardware integration, and AI.

• Take ownership of the software verification and validation strategy for SaMD, ensuring bi-directional traceability from requirements and risk controls to test evidence.

• Define testing and monitoring protocols for AI/ML systems, encompassing model performance validation, dataset quality assessments, bias and robustness testing, model-version regression, and post-deployment drift and performance monitoring.

• Integrate quality practices into the Software Development Life Cycle (SDLC) through shift-left methodologies, CI/CD quality gates, and automated regression, performance, security, and accessibility testing.

• Align engineering processes with the Quality Management System and act as a technical authority during audits conducted by notified bodies and regulatory authorities.

• Promote risk-based thinking with product and clinical teams regarding risk analysis, hazard mitigation, and verification of risk controls in accordance with ISO 14971.

• Assess and implement tools for test management, automation, and automated traceability.

• Report directly to the VP of Quality Assurance and Regulatory Affairs (QARA) while collaborating with Engineering, Product, and AI teams.

⛳️ Requirements

• Over 7 years of experience in software quality engineering, including more than 5 years in leadership roles managing quality teams (both managers and individual contributors) within a regulated environment.

• Practical experience with medical device software or similar regulated sectors.

• Familiarity with IEC 62304, ISO 13485, ISO 14971, ISO/IEC 42001, IEC 81001-5-1, FDA 21 CFR Part 820 / QMSR, and/or EU MDR standards.

• Demonstrated success in building and scaling test automation and CI/CD quality practices across various product teams.

• Experience in defining verification and validation strategies and producing evidence that can withstand audits or regulatory submissions.

• Capability to review system architectures, testing frameworks, and code, along with mentoring engineers.

• Proven history as a Team Lead or manager with direct responsibilities for hiring, mentoring, and guiding technical quality teams.

• Exceptional communication and influencing skills when interacting with executives, engineers, clinicians, and regulators.

• Must exhibit at least Level 1 proficiency in AI.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Flexible work hours and remote work options.

• Professional development and training opportunities.

• Collaborative and innovative work environment.