VP of Quality

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Описание

About Inspiren Inspiren offers the most complete and connected ecosystem in senior living. Founded by Michael Wang, a former Green Beret turned cardiothoracic nurse, Inspiren proves that compassionate care and technology can coexist - bringing peace of mind to residents, families, and staff. Our integrated solutions seamlessly fit into existing workflows, capturing everything happening within a community. Backed by nurse specialists and powerful analytics, we provide the data operators need to make informed clinical and operational decisions - driving efficiency, profitability, and better care outcomes. What You'll Lead ISO 13485 Certification — Your North Star 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 QMS Architecture in a PLM Environment 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

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