Director of Quality

Location: Boston, MA, USA (On-site, 10% travel) | Type: Full-time Work Arrangement: Hybrid - 3 days onsite / 2 days remote Reports to: CEO | Team: Quality About PhAST PhAST develops leading technology for microbiology, combining single-cell imaging, microfluidics, and AI computer vision. The first product, the PhAST Blood Culture Gram-negative Panel, delivers Antimicrobial Susceptibility Testing (AST) results for positive blood cultures in 100 minutes for a panel of 15 antibiotics and the majority of Gram-negative pathogens, and received FDA 510(k) clearance (K253316) in June 2026. We are now developing U.S. commercialization post-clearance and the quality system to support it. Job Description PhAST is seeking its Director of Quality to own the company's Quality Management System (QMS) and lead it through commercial launch and beyond. This is a hands‑on, build-and‑run role: the successful candidate will extend PhAST's QMS from its current product‑development foundation into a fully operational system for commercialization and post‑market — preparing PhAST for its first FDA inspection and for ISO 13485 certification. The immediate priority is US commercial launch under the QMSR (21 CFR Part 820, incorporating ISO 13485:2016). In parallel, this role builds the foundation for PhAST's international ambitions — ISO 13485:2016 and MDSAP certification, and CE Marking / IVDR, as PhAST expands into international markets. The Director of Quality serves as the Management Representative, is the company's authority and source of truth on quality, and works closely with every team (Product, Data, Engineering, Software, R&D, Clinical) and with PhAST's contracting partners (contract manufacturers and CROs). This role owns PhAST's QMS end‑to‑end, working alongside team members with QMS experience and current outside consulting support — with the expectation of building a dedicated in‑house function and team over time. As an AI‑native company, we expect this role to make full use of AI/LLM tools to accelerate documentation, cross‑referencing, and ongoing QMS management, building a quality system as modern and efficient as the rest of PhAST. Responsibilities Build & Run the QMS Own, implement, and continuously improve PhAST's QMS in conformance with the QMSR (21 CFR 820 / ISO 13485:2016). Own document control, records, and training. Finish the launch‑critical procedures and reconcile the full SOP framework (e.g., UDI, registration & listing, reportable events & recall). Lead efforts to achieve and maintain ISO 13485:2016 certification; support CE Marking / IVDR, MDSAP, and multi‑site (US/EU/Asia) quality operations; support future EU PRRC planning. Ensure design controls, design verification/validation, risk management, and design transfer are performed per applicable requirements, coordinating with Product, Software, Engineering, Data, and R&D; ensure Design History Files are audit-worthy. Launch & FDA‑inspection readiness Own FDA establishment registration & listing, UDI/GUDID, and device labeling & packaging controls (§820.45). Own audit‑readiness and lead PhAST's first FDA inspection; schedule and run internal audits and host external/third‑party/ISO/FDA audits; communicate findings and drive CAPAs to closure. Help coordinate regulatory affairs work (submissions, gap assessments) with team support. Review marketing and website claims to ensure consistency with the cleared intended use. Support future submissions and the PCCP pathway. Run complaint handling, Medical Device Reporting (MDR, 21 CFR 803), and corrections & removals / recalls (21 CFR 806). Operate post‑market surveillance and a recurring management review / Quality Review Board that tracks nonconformances, CAPAs, complaints, investigations, and in‑field product performance. Manage supplier and contract‑manufacturer quality — quality agreements, supplier qualification and audits, incoming inspections, and Device History Record / Certificate of Conformance review. Qualifications 7+ years in Quality Assurance / Quality Management in the in vitro diagnostics (IVD) or medical device industry, including several years in a quality leadership role. Experience standing up or operationalizing a QMS (building a system from a partial state, not only maintaining a mature one) — ideally in a startup/scale‑up. Demonstrated, hands‑on use of AI/LLM tools to accelerate quality and documentation work required. Working knowledge of the QMSR / 21 CFR 820. Strong familiarity with the applicable industry standards — ISO 13485:2016, ISO 14971, IEC 62304, and relevant CLSI guidelines for antimicrobial susceptibility testing. Direct experience hosting and managing an FDA inspection strongly preferred. Experience leading a company through an accredited ISO 13485 certification audit (Stage 1/Stage 2) strongly preferred. MDSAP / CE / IVDR exposure a plus. Experience owning design controls — verification/validation, risk management, and Design History File management — for a complex regulated device (experience with hardware/software combination products a plus). Experience with post‑market activities — complaints, MDR, CAPA, post‑market surveillance — for a commercialized device. Experience with supplier/contract‑manufacturer quality, including OUS manufacturers (quality agreements, supplier audits, incoming inspection). Experience supporting US 510(k) post‑clearance commercialization (registration, listing, UDI, labeling) preferred. Bachelor's degree in a science, engineering, or related field (or equivalent experience) Clear, precise communicator comfortable working across diverse, interdisciplinary teams in a fast‑moving environment. PhAST is an Equal Opportunity Employer. We are committed to building a diverse team and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, or any other characteristic protected by applicable law. Candidates must be authorized to work in the United States. #J-18808-Ljbffr PhAST