VP of Quality

This is a fully remote position, open to applicants in New York.

📋 Description

• Take ownership of the company's ISO 13485 certification strategy, starting from the initial gap analysis to successful third-party audits and ongoing surveillance.

• Develop and implement the Quality Management System (QMS), integrating it with existing engineering tools and processes (Linear, Propel, Notion, Hardfin, Logistics+) whenever feasible, while introducing new systems only when necessary.

• Utilize your direct, hands-on certification experience to foresee audit risks, plan the work effectively, and guide internal teams with assurance.

• Act as the main point of contact with notified bodies and registrars throughout the certification process and beyond.

• Establish and uphold essential QMS processes, including document control, CAPA, internal audits, management reviews, complaint handling, and post-market surveillance.

• Collaborate with engineering leadership to implement and configure the QMS within the company's Product Lifecycle Management (PLM) platform, ensuring quality processes and engineering workflows are seamlessly integrated.

• Define the structure, ownership, and maintenance of design controls, change management, document control, and risk management artifacts within the PLM environment.

• Create a traceability framework linking requirements, design outputs, verification and validation records, and risk management documents — all managed within the PLM system.

• Foster alignment between quality and engineering regarding data ownership, workflow approvals, and record integrity to support daily operations and audit preparedness.

• Continuously assess and enhance PLM-based QMS workflows as the product portfolio and team grow.

• Formulate quality plans, inspection criteria, and verification and validation strategies for electromechanical and software-embedded products.

• Integrate quality activities — including FMEA, design reviews, and risk management per ISO 14971 — into the product development lifecycle without hindering progress.

• Specify QMS requirements for software quality processes in accordance with IEC 62304, collaborating with the Director of QA to ensure compliance without overlapping responsibilities.

• Lead root cause analysis and corrective actions for hardware quality incidents.

• Serve as the main liaison between Inspiren (Customer Success) and customers regarding reported hardware quality concerns.

• Drive root cause analysis and corrective actions, including creating quality reports that meet customer satisfaction.

• Build, mentor, and cultivate a lean, high-performing quality team — the individuals you recruit and develop will shape the quality function's identity at Inspiren.

• Lead with transparency and psychological safety: uphold high standards while fostering an environment where quality issues can be raised early in the process.

• Mentor quality engineers and specialists across hardware, software, and supplier quality areas, enhancing their technical expertise and ownership mindset.

• Influence cross-functionally without authority, promoting quality as a shared value rather than a compliance obligation.

• Represent the quality function at the leadership level, advocating for the necessary resources and processes to establish a world-class QMS.

• Ensure a rigorous manufacturing quality program to promote a zero-defect philosophy and outcomes across SMT and FA with our JDM partners (6 sigma program).

• Develop a supplier quality program tailored for a scaling company, including qualification processes, incoming inspections, supplier audits, and Quality Agreements with key vendors.

• Implement risk-based oversight for critical suppliers and Contract Manufacturing Organizations (CMOs), along with scorecards and improvement plans where necessary.

⛳️ Requirements

• Over 10 years of quality experience in the medical device sector, with progressively increasing leadership responsibilities.

• Multiple ISO 13485 certifications that you have personally led or co-led — this is the most crucial qualification for this role; please specify in your application the quantity, scope, and your direct involvement with each.

• Practical experience in establishing a QMS from the ground up within a PLM environment.

• A proven track record of building, leading, and nurturing quality teams — focusing not just on process management but also on personnel development.

• Proficient understanding of 21 CFR Part 820, ISO 14971, and IEC 62304.

• Experience across hardware/systems quality, software quality, and supply chain quality — breadth of experience is essential here.

• Demonstrated capability to create or significantly enhance a QMS at an organization that previously lacked one.

• Strong communicator and collaborator capable of effectively engaging with engineers, executives, and auditors alike.

🏝️ Benefits

• Equity

• Comprehensive benefits package (including medical, dental, and vision coverage)

• Flexible paid time off