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 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 Hardware, Software & Systems Quality 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 Customer Quality 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. People & Team Leadership 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 Supply Chain Quality 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 What You Bring Must-Haves 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 Strong Pluses Deep familiarity with PLM-QMS integration — experience configuring or optimizing quality workflows within platforms such as Windchill, Teamcenter, Arena, or Vault Prior experience as a Management Representative or Quality System owner at a growth-stage company ASQ CQE, CQM/OE, or CQA certification Background supporting FDA inspections for 510(k) or De Novo product types Experience mentoring early-career quality professionals and building quality team culture from the ground up Details The annual salary for this role is $260,000-$300,000 + equity + benefits (including medical, dental, and vision) Flexible PTO Location: Remote, US or Canada - NYC preferred