10+ years of quality experience in medical devices, with increasing leadership responsibility
Multiple ISO 13485 certifications personally led or co-led
Hands-on experience building a QMS from scratch within a PLM environment
Proven track record of building, leading, and developing quality teams
Experience across hardware, software, and supply chain quality
Strong communicator who operates effectively with engineers and executives
Responsibilities
Own the company's ISO 13485 certification roadmap from gap assessment to audit
Design and build the QMS integrating with existing engineering tools
Serve as primary liaison with notified bodies and registrars
Partner with engineering to configure the QMS within PLM
Define structure and maintenance of design controls and change management within PLM
Establish customer quality processes and root cause analysis
Lead the development of a robust manufacturing quality program with JDM partners
Benefits
Flexible PTO
Remote work option for US or Canada
Comprehensive health benefits (medical, dental, vision)
Full Job Description
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)
