VP of Quality

🕒 Maio 15

🗽 New York – Remoto

🗽 New York – Remote

💵 $260.000 - $300.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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Inspiren

SiteLinkedInTodas as Vagas

1 - 10 funcionários

⚕️ Seguro de Saúde

☁️ SaaS

🧘 Bem-estar

💰 $2.700.000 Venture Round em 2022-10

Healthcare Insurance • SaaS • Wellness

Inspiren é uma solução abrangente para gerenciar e otimizar operações em comunidades de vivência para idosos. A plataforma aprimora o cuidado aos residentes ao fornecer análise de dados de nível decisório para planejamento de cuidados, otimização de equipe e segurança dos residentes. A Inspiren utiliza tecnologia avançada, como o AUGi, para permitir cuidados proativos, melhorar a eficiência do fluxo de trabalho e alinhar os planos de cuidados com as necessidades dos residentes. As capacidades da tecnologia incluem alertas em tempo real para incidentes e sinalização precoce de riscos, rastreamento de interações dos residentes e monitoramento da eficácia da equipe, assegurando assim cuidados de alta qualidade aos residentes e eficiência operacional.

Descrição

• Own the company's ISO 13485 certification roadmap from initial gap assessment through successful third-party audit and ongoing surveillance • Design and build the QMS, integrating with existing engineering tools and workflows (Linear, Propel, Notion, Hardfin, Logistics+) wherever possible and introducing new systems only where gaps require it • Leverage your direct, hands-on certification experience to anticipate audit risk, sequence the work intelligently, and lead internal teams with confidence • Serve as the primary liaison with notified bodies and registrars throughout the certification process and beyond • Establish and maintain core QMS processes: document control, CAPA, internal audit, management review, complaint handling, and post-market surveillance • Partner with engineering leadership to stand up and configure the QMS natively within the company's PLM platform, ensuring quality processes and engineering workflows are integrated rather than siloed • Define how design controls, change management, document control, and risk management artifacts are structured, owned, and maintained inside the PLM environment • Establish traceability architecture between requirements, design outputs, verification & validation records, and risk management files — all managed within PLM • Drive alignment between quality and engineering on data ownership, workflow approvals, and record integrity to support both day-to-day development and audit readiness • Evaluate and continuously improve PLM-based QMS workflows as the product portfolio and team scale • Define quality plans, inspection criteria, and V&V strategies for electromechanical and software-embedded products • Integrate quality activities — FMEA, design reviews, risk management per ISO 14971 — into the product development process without slowing it down • Define QMS requirements for software quality processes aligned with IEC 62304, and partner with the Director of QA to ensure compliance without duplicating ownership • Lead root cause analysis and corrective action on hardware quality escapes • Act as the primary liaison between Inspiren (Customer Success) and Customer relating to hardware quality issues reported by our customers • Drive root cause analysis and correct actions, including developing quality reports to the satisfaction of our customers. • Build, mentor, and develop a lean, high-performing quality team — the people you hire and grow will define the quality functions DNA at Inspiren • Lead with clarity and psychological safety: set high standards while creating an environment where quality issues surface early, not late • Coach quality engineers and specialists across hardware, software, and supplier quality disciplines, growing their technical depth and ownership mindset • Influence without authority across engineering, operations, and product teams — making quality a shared value, not a policing function • Represent the quality function at the leadership level, advocating for the resources and processes needed to build a world-class QMS • Ensure a rigorous manufacturing quality program to embody a zero-defect mindset and outcome across SMT and FA with our JDM partners (6 sigma program) • Build a supplier quality program appropriate for a scaling company: qualification processes, incoming inspection, supplier audits, and Quality Agreements with critical vendors • Develop risk-based oversight for key suppliers and CMOs, with scorecards and improvement plans where needed

🎯 Requisitos

• 10+ years of quality experience in medical devices, with increasing leadership responsibility • Multiple ISO 13485 certifications personally led or co-led — this is the single most important qualification for this role; please be specific in your application about the number, scope, and your direct ownership of each • Hands-on experience building a QMS from scratch within a PLM environment • A proven track record of building, leading, and developing quality teams — not just managing processes, but developing people • Working knowledge of 21 CFR Part 820, ISO 14971, and IEC 62304 • Experience spanning hardware/systems quality, software quality, and supply chain quality — breadth matters here • Demonstrated ability to build or significantly mature a QMS at a company that didn't yet have one • Strong communicator and collaborator who can operate effectively with engineers, executives, and auditors alike.

🏖️ Benefícios

• equity • benefits (including medical, dental, and vision) • Flexible PTO