Director of AI-enabled Quality Systems (Burlington)

As a Director of AI-enabled Quality Systems, you will own the day-to-day execution and continuous improvement of SiPhox’s Quality Management System (QMS), supporting the development, validation, and production of regulated products from early prototypes through clinical and manufacturing stages. This is a hands-on, high-impact role in a fast-moving, multidisciplinary environment where quality must keep pace with innovation. You will work closely with engineering, operations, and clinical teams to ensure that products, processes, and documentation meet internal requirements and applicable regulatory standards. Your focus will be on practical quality execution, ensuring verification and validation (V&V), design controls, and production systems are implemented effectively, issues are resolved efficiently, and results can be trusted. In this role, you will serve as both a quality gatekeeper and a collaborative partner, helping teams build compliant processes without slowing progress. You will also play a key role in strengthening and scaling the QMS as the company grows, identifying opportunities to improve efficiency, clarity, and robustness across development and operations. This role will have a high impact on SiPhox’s success, with significant potential for career development and growth as the company progresses through FDA submissions, manufacturing ramp up, and product launch. Responsibilities Quality System Leadership Serve as a senior owner and architect of the ISO 13485 Quality Management System (QMS), ensuring scalability, inspection readiness, and alignment with FDA (21 CFR 820 / QMSR), EU IVDR (if applicable), and other global requirements. Lead strategic evolution of document and record control processes, ensuring robust change control, traceability, and configuration management across design and manufacturing. Drive quality system maturity, ensuring processes are right-sized for a high-growth, fast-paced medical device environment. Design Controls & Product Development Lead and oversee design control activities in accordance with 21 CFR 820.30 and ISO 13485, ensuring clear traceability from user needs through verification, validation, and risk management. Partner with engineering, assay development, software, and operations teams to embed quality into product development from concept through commercialization. Ensure Design History Files (DHFs), Device Master Records (DMRs), and technical documentation are complete, audit-ready, and submission-ready. Regulatory Submission Support Lead quality strategy and documentation support for FDA submissions (510(k), De Novo, etc.), including substantial involvement in at least one cleared IVD submission. Ensure verification & validation documentation, risk files, and QMS elements meet regulatory expectations. Support responses to FDA questions, deficiency letters, and inspection observations. CAPA & Continuous Improvement Own and elevate the CAPA system, ensuring robust investigations, root cause analysis (e.g., 5-Why, Fishbone, FMEA), and effective corrective actions. Analyze quality data trends to identify systemic risks and drive proactive improvement. Mentor cross-functional teams in structured problem-solving methodologies. Risk Management Lead risk management activities in accordance with ISO 14971. Ensure risk controls are appropriately linked to design inputs, verification/validation, production controls, and post-market activities. Drive integration of risk management throughout the product lifecycle. Audit & Inspection Readiness Lead internal audit programs and supplier quality audits. Serve as a primary quality representative during ISO 13485 audits and FDA inspections. Drive timely and effective responses to audit findings and regulatory observations. Post-Market & Compliance Oversee complaint handling, adverse event reporting (e.g., MDR), and post-market surveillance processes. Ensure effective feedback loops between post-market data and design/process improvements. Training & Culture Architect and maintain a scalable, role-based training system with measurable effectiveness. Promote a strong culture of quality, ownership, and compliance across the organization. Required Qualifications 8+ years of experience in medical device quality within an ISO 13485 environment. 5+ years of experience in IVD development and/or manufacturing. Direct participation in one or more successful FDA 510(k) submissions for an IVD device. Deep working knowledge of: ISO 13485 21 CFR 820 (and QMSR transition awareness) ISO 14971 Design controls for IVD systems (including assay and/or instrument development) Demonstrated experience leading CAPA investigations and cross-functional quality initiatives. Experience serving as a key quality representative during external audits or inspections. Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred). Authorized to work in the U.S. without sponsorship. Highly Desirable Experience Experience with combination systems (instrument + consumable IVD). Experience in CLIA-regulated laboratory environments. Experience with software quality (IEC 62304 familiarity). Experience building or significantly scaling a QMS in a startup environment. Experience supporting international submissions (CE marking under IVDR). Additional notes SiPhox Health is creating an entirely new category of at-home technology that brings advanced biological measurement into everyday life. Our platform brings together silicon photonics, microfluidics, motion systems, sensing, thermal control, and embedded computing inside a compact device that performs complex biochemical analysis in minutes. We are building a consumer product that has never existed before. It integrates optics, chemistry, mechanics, biology and electronics into a seamless experience designed for millions of homes. We offer competitive benefits, including a Life Time Fitness membership and the opportunity to work in a fast-paced, mission-driven environment building the future of home health.