Director of Quality Engineering

Job not on LinkedIn

🔥 6 minutes ago

🇵🇹 Portugal – Remote

💵 €64.4k - €101.2k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 2%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Sword Health

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Sword Health is a digital health company that combines artificial intelligence with clinical expertise to provide world-class care for muscle, joint, and pelvic health conditions. By offering digital physical therapy and AI-driven care, Sword helps individuals recover from physical ailments from the comfort of their own home, avoiding surgeries and reducing the need for medications. The company provides employers, health plans, and individuals with personalized treatment plans that are cost-effective and have proven outcomes in pain reduction and improved productivity. Sword Health is dedicated to expanding access to high-quality care and ensuring health equity across global communities.

📋 Description

• Define and lead the end-to-end quality strategy across Software as a Medical Device (SaMD), AI/ML, and connected-device products • Help set the vision for quality across web, mobile, backend, firmware/hardware integration, and AI • Own software verification and validation strategy for SaMD, ensuring bi-directional traceability from requirements and risk controls through test evidence • Define testing and monitoring for AI/ML systems, including model performance validation, dataset quality, bias and robustness testing, model-version regression, and post-deployment drift and performance monitoring • Embed quality into the SDLC through shift-left practices, CI/CD quality gates, automated regression, performance, security, and accessibility testing • Align engineering processes with the Quality Management System and serve as a technical authority during audits by notified bodies and authorities • Drive risk-based thinking with product and clinical teams on risk analysis, hazard mitigation, and verification of risk controls under ISO 14971 • Evaluate and introduce tooling for test management, automation, and automated traceability • Report to the VP of QARA and collaborate with Engineering, Product, and AI teams

🎯 Requirements

• 7+ years in software quality engineering, with 5+ years leading quality organizations (managers and ICs) in a regulated environment • Hands-on experience with medical device software or comparable regulated domains • Working knowledge of IEC 62304, ISO 13485, ISO 14971, ISO/IEC 42001, IEC 81001-5-1, FDA 21 CFR Part 820 / QMSR and/or EU MDR • Proven track record building and scaling test automation and CI/CD quality practices across multiple product teams • Experience defining V&V strategies and producing evidence that stood up to audits or regulatory submissions • Ability to review architectures, test frameworks, and code, and coach engineers • Proven track record as a Team Lead or manager directly hiring, mentoring, and steering technical quality teams • Excellent communication and influence skills with executives, engineers, clinicians, and regulators • Demonstrate at least Level 1 AI proficiency

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