Director of Quality & Regulatory Strategy

SiPhox Health is building something that has never existed before: a consumer device that performs complex biochemical analysis at home in minutes, combining silicon photonics, microfluidics, motion systems, and embedded computing into a seamless experience designed for millions of households. We're at an inflection point, moving from development through FDA submission, manufacturing ramp, and product launch. We need a Director of Quality who has been here before: someone who can hold the rigor of a regulated medical device environment without killing the speed a startup requires. This is a hands-on, high-ownership role. You will be the senior quality leader in the company, reporting directly to the executive team, and the primary architect of how we build, validate, and ship a regulated IVD product that people will trust with their health. What You'll Own Quality System You’ll own and evolve our ISO 13485 QMS, not just maintain it. That means right-sizing processes for a 70-person company moving fast, ensuring we’re inspection-ready without drowning in overhead, and scaling the system as we grow. Document control, change control, traceability, configuration management, all of it is yours. Design Controls & Product Development You’ll be embedded with engineering, assay development, software, and operations to ensure design controls are real and functional, not a documentation exercise. DHFs, DMRs, V&V plans, risk files; you’ll ensure they’re complete, coherent, and submission-ready. You know the difference between a traceable design history and a paper trail assembled after the fact. FDA Submission You’ve done this before. You’ll lead quality strategy and documentation for our FDA submission (510(k) or De Novo), own the V&V and risk documentation, and be the person who fields deficiency letters and inspection observations without flinching. CAPA & Root Cause You’ll run a CAPA system that actually closes problems, with rigorous root cause analysis (5‑Why, Fishbone, FMEA), real corrective actions, and verified effectiveness. You’ll also be the person who teaches the rest of the organization to think this way. Risk Management You’ll lead risk management under ISO 14971 across the full product lifecycle, ensuring risk controls connect meaningfully to design inputs, V&V, production, and post‑market data. Audits & Inspections You’ll own the internal audit program, lead supplier audits, and serve as the primary quality representative in front of notified bodies and FDA. When an auditor walks in, you’re ready. Post‑Market Complaint handling, MDR reporting, post‑market surveillance, you’ll ensure feedback from the field loops back into design and process improvements. What We’re Looking For 8+ years in medical device quality within an ISO 13485 environment 5+ years in IVD development and/or manufacturing Direct, hands‑on involvement in at least one successful FDA 510(k) clearance for an IVD, you know what that process actually takes Deep working knowledge of ISO 13485, 21 CFR 820 / QMSR, ISO 14971, and IVD design controls (assay and/or instrument) Experience leading CAPA investigations and driving cross‑functional quality initiatives Experience as the primary quality contact during external audits or FDA inspections Bachelor's in engineering, life sciences, or related field; advanced degree a plus Must be authorized to work in the U.S. without sponsorship Particularly compelling if you also have: Experience with combination systems (instrument + consumable IVD) QMS build‑out or scale‑up experience at a startup IEC 62304 software quality familiarity Who Thrives Here You’re energized by complexity and ambiguity, not paralyzed by it. You hold high standards without being rigid. You know when a process needs more structure and when it needs to get out of the way. You can write a thorough audit response in the morning and sit in a design review in the afternoon. You’ve seen the consequences of cutting corners in a regulated product and you won’t let it happen, but you also understand what it takes to ship. Why SiPhox You’ll be the quality leader at a company building a genuinely novel product category Direct path to VP of Quality as the company grows through launch and scale Competitive compensation and equity Lifetime Fitness membership Mission‑driven team building technology that will meaningfully change how people understand their own health and manage their chronic disease. #J-18808-Ljbffr SiPhox Health