Job Description
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
