VP of Quality

Inspiren offers a connected ecosystem in senior living, combining compassionate care and technology to improve outcomes for residents, families, and staff. The company is seeking a Quality leader to oversee ISO 13485 certification, QMS architecture, hardware, software, and systems quality, customer quality, team leadership, and supply chain quality.

Location: Remote, US or Canada - NYC preferred

Salary: $260,000–$300,000 + equity + benefits

Responsibilities

• 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.

Requirements

• 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.

Benefits

• The annual salary for this role is $260,000-$300,000 + equity + benefits (including medical, dental, and vision).
• Flexible PTO

Additional Information

• Location: Remote, US or Canada - NYC preferred