Inspiren
senior living
VPofQuality
Neural analysis suggests this role is
optimal for Director candidates.
“VP of Quality at Inspiren. Skills: ISO 13485 Certification, QMS Design and Build, PLM Integration. 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 wherever possible and introducing new systems only where gaps require it”
What You'll Achieve.
Successful third-party audit; Ongoing surveillance; Driving efficiency; Profitability; Better care outcomes
Industry & Context.
Remote, US or Canada - NYC preferred
What They're Looking For.
Must Have
Hands-on experience building a QMS from scratch within a PLM environment, A proven track record of building, leading, and developing quality teams, Working knowledge of 21 CFR Part 820, Working knowledge of ISO 14971, Working knowledge of IEC 62304, Experience spanning hardware/systems quality, Experience spanning software quality, Experience spanning supply chain quality, Demonstrated ability to build or significantly mature a QMS at a company that didn't yet have one
Nice to Have
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
What You'll Do.
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 wherever possible and introducing new systems only where gaps require it
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
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
and risk management artifacts are structured
and maintained inside the PLM environment
Establish traceability architecture between requirements
How You'll Work.
Team & Collaboration
Partner with engineering leadership; Lead internal teams with confidence; Operate effectively with engineers, executives, and auditors alike
Communication Scope
Communicator and collaborator who can operate effectively with engineers, executives, and auditors alike
Process & Methodology
Sequence the work intelligently
Full 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 please be specific in your application about the number, scope, and your direct ow
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