VP of Quality

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