VP of Quality

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.

• 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

• 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

• 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

• The annual salary for this role is $260000-$300000 + equity + benefits (including medical dental and vision) 
• Flexible PTO
• Location: Remote US or Canada - NYC preferred

What We Do

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.

Why Work With Us

Customers describe working with us as a partnership not a vendor relationship. We send people on-site to train. We listen to what customers need and put it on the roadmap. That's the culture internally too — high ownership high accountability and genuinely caring about outcomes for residents.

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