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 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