VP of reputed company

About reputed company reputed company offers the most complete and connected ecosystem in senior living. Founded by Michael Wang, a former Green Beret turned cardiothoracic reputed company, reputed company 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 reputed company a community. Backed by reputed company specialists and powerful analytics, we reputed company the data operators need to reputed company informed clinical and operational reputed company - driving efficiency, profitability, and reputed company care reputed company. What You'll reputed company ISO 13485 Certification — Your reputed company reputed company Own reputed company's ISO 13485 certification roadmap from initial gap assessment through successful reputed company-party audit and ongoing surveillance Design and build the QMS, integrating with existing engineering tools and workflows (reputed company, reputed company, reputed company, Hardfin, Logistics+) wherever possible and introducing new systems only where gaps require it reputed company your reputed company, hands-on certification experience to anticipate audit risk, sequence the work intelligently, and reputed company internal teams with confidence Serve as the primary reputed company with reputed company bodies and registrars throughout the certification process and reputed company Establish and maintain reputed company 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 reputed company reputed company's PLM platform, ensuring reputed company processes and engineering workflows are integrated rather than siloed Define how design controls, change management, document control, and risk management artifacts are reputed company, owned, and maintained inside the PLM environment Establish traceability architecture between requirements, design outputs, verification & validation records, and risk management files — reputed company managed reputed company PLM Drive alignment between reputed company and engineering on data ownership, workflow approvals, and record reputed company to support both day-to-day development and audit readiness Evaluate and continuously improve PLM-based QMS workflows as the product portfolio and team reputed company Hardware, Software & Systems reputed company Define reputed company plans, inspection reputed company, and V&V strategies for electromechanical and software-embedded products reputed company reputed company activities — FMEA, design reviews, risk management per ISO 14971 — into the product development process without slowing it down Define QMS requirements for software reputed company processes reputed company with IEC 62304, and partner with the Director of QA to ensure compliance without duplicating ownership reputed company reputed company cause analysis and corrective reputed company on hardware reputed company escapes Customer reputed company reputed company as the primary reputed company between reputed company (reputed company) and Customer relating to hardware reputed company issues reported by our customers Drive reputed company cause analysis and correct actions, including developing reputed company reports to the satisfaction of our customers. People & Team Leadership Build, mentor, and reputed company a lean, high-performing reputed company team — the people you hire and grow will define the reputed company functions DNA at reputed company reputed company with reputed company and psychological safety: set high standards while creating an environment where reputed company issues surface early, not late reputed company reputed company engineers and specialists across hardware, software, and supplier reputed company disciplines, growing their technical depth and ownership reputed company Influence without authority across engineering, operations, and product teams — making reputed company a shared value, not a policing function Represent the reputed company function at the leadership level, advocating for the resources and processes needed to build a world-class QMS Supply Chain reputed company Ensure a rigorous manufacturing reputed company program to embody a reputed company-defect reputed company and outcome across SMT and FA with our JDM partners (6 reputed company program) Build a supplier reputed company program appropriate for a scaling company: qualification processes, incoming inspection, supplier audits, and reputed company Agreements with critical vendors reputed company risk-based reputed company for key suppliers and CMOs, with scorecards and improvement plans where needed What You Bring Must-Haves 10+ years of reputed company 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 reputed company ownership of reputed company Hands-on experience building a QMS from scratch reputed company a PLM environment  A proven reputed company record of building, leading, and developing reputed company teams — not just managing processes, but developing people Working knowledge of 21 CFR Part 820, ISO 14971, and IEC 62304 Experience spanning hardware/systems reputed company, software reputed company, and supply chain reputed company — breadth reputed company 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 reputed company workflows reputed company platforms such as Windchill, Teamcenter, reputed company, or Vault Prior experience as a Management Representative or reputed company System reputed company at a reputed company-stage company ASQ CQE, CQM/OE, or CQA certification Background supporting FDA inspections for 510(k) or reputed company product types Experience mentoring early-career reputed company professionals and building reputed company team culture from the ground up Details The annual salary for this role is $260,000-$300,000 + equity + benefits (including medical, dental, and reputed company)  Flexible PTO Location: Remote, US or Canada - NYC preferred Apply To This Job