{"id":2101941,"url":"https://alion.io/job/synthbee-director-of-quality","title":"Director of Quality","company":{"id":3868116,"name":"SynthBee","domain":"synthbee.com","url":"https://alion.io/company/synthbee","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Pembroke Pines, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":109000,"max_usd":216000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":668},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"21 CFR Part 820","optional":true},{"name":"Computer Use","optional":true},{"name":"Design Controls","optional":true},{"name":"Design History File","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-09-14T16:43:31Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-11-01T06:56:03Z","board_verified":true,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":47},"description":"ABOUT SYNTHBEE\nSynthBee was founded to build safe, scalable, and reliable Collaborative Intelligence™ to amplify human innovation. We apply our novel computing intelligence platform to complex, mission-critical systems across healthcare, defense, aerospace, automotive, robotics, security, climate, and more-for customers who demand reliability, transparency, and ethics above all.\nABOUT THE ROLE\nAs our Director of Quality, you will own the strategic vision, architecture, and execution of a right-sized, scalable Quality Management System (QMS) across SynthBee’s high-growth, regulated multi-industry environment. Moving beyond just managing processes, you will serve as the champion of quality culture, embedding it deeply into our engineering, product, and operational lifecycles.\nWHAT YOU'LL DO\nYou will partner directly with executive leadership to scale our operations responsibly, transition the QMS from scratch to high-maturity, and ultimately build out a high-performing Quality department. This role requires a visionary leader who is equally comfortable defining a multi-year compliance roadmap and stepping in to architect complex validation frameworks.\nKey Responsibilities & Strategic Deliverables\nLeadership & Strategy: Define and execute the corporate quality strategy, aligning compliance roadmaps with overall business goals, product launch timelines, and multi-industry expansions.\nQMS Governance & Architecture: Oversee the implementation, evolution, and continuous improvement of a unified QMS infrastructure capable of supporting concurrent compliance frameworks.\nOrganizational Scaling: Recruit, mentor, and develop a world-class Quality engineering and compliance team as the company grows. Partnering with Talent Acquisition and the VP of Mission Control to define requirements for new hires.\nCross-Functional Engineering Alignment: Partner with Software, IT, and AI Engineering leaders to embed unified quality standards across integrated, complex systems.\nRegulatory & Audit Ownership: Act as the ultimate authority for internal and external audits, regulatory submissions, and formal CAPA strategies; maintain a constant state of global inspection-readiness.\nRisk Management Management: Establish corporate risk assessment frameworks, overseeing root cause investigations and effectiveness checks at an enterprise level.\nWHAT YOU'LL BRING\nRequired Skills & Technical Competencies\nEnterprise QMS Strategy: Mastery in designing, scaling, and managing QMS infrastructures aligned with ISO 9001, with a focus on cross-industry flexibility.\n Multi-Disciplinary Engineering Integration: Deep experience bridging complex software (including AI/ML frameworks) and hardware engineering lifecycles.\nAgile Governance at Scale: Expert at integrating Agile and DevOps development practices into highly regulated environments, balancing rapid deployment with rigorous traceability.\nAudit Leadership & Regulatory Liaison: Proven track record of interacting directly with regulatory bodies, managing high-stakes external audits, and defending compliance methodologies.\nOperational Optimization: Proven ability to streamline corporate workflows, eliminating bureaucratic bloat without sacrificing compliance or product safety.\nPreferred Qualifications\nMulti-Industry Standards Expertise: Deep technical knowledge, oversight, or certification in one or more of the following: Medical Device: ISO 13485 & FDA 21 CFR Part 820 (QSR), SaMD (Software as a Medical Device).\nAerospace:\nAutomotive: IATF 16949.\n\n Lifecycle Lifecycle Governance: Experience governing Design Controls (DHF, DMR, DHR) and integrating quality from early-stage R&D through post-market surveillance.\n Experience & Education: 10+ years of progressive quality experience in highly regulated technical fields, with at least 3-5 years in a leadership/management capacity; Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field (Master’s/MBA preferred).\n Certifications: ASQ certifications (CMQ/OE, CQE, CQA) or equivalent professional credentials are highly desirable.\nNot sure you check every box? Apply anyway. At SynthBee, we value unique perspectives, transferable skills, and a genuine growth mindset. If this work excites you and your experience aligns with the core responsibilities, we want to hear from you.\nYOU SHOULD APPLY IF\nYou love solving problems that don't have textbook answers. You build as naturally as you think, and you want your work to matter-for people, for the planet, for the future of intelligence. You're creative, imaginative, and deeply ethical. You believe in decency and collaboration. You are not here to follow the crowd.\nWORKING CONDITIONS\nThis is a full-time, in-person role at SynthBee HQ in Pembroke Pines, FL, Monday through Friday. The role requires extended periods of computer use, research, and code development. Our office is a dynamic, high-energy environment built for the kind of deep collaboration and creative problem-solving that thrives in person. Reasonable accommodations will be provided in accordance with the ADA. Please refer to the BeeKeeper's Guide for details.\nOUR COMMITMENT TO YOU\nSynthBee is proud to be an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local law. 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