Hubot, Inc. is an FDA-registered contract development and manufacturing organization (CDMO) serving global pharmaceutical and personal care brands — including Fortune 500 clients. With 25–30% projected year-over-year growth through 2030, we're building the infrastructure, systems, and team to match world-class ambition.This position is not eligible for visa sponsorship.The Opportunity :Quality isn't just a department here — it's the foundation of everything we ship. We're looking for a Senior Quality Engineer to help us maintain that standard as we scale, bringing GMP expertise, sharp root-cause analysis skills, and hands-on eQMS experience to a team responsible for keeping our products safe, compliant, and audit-ready. You'll have real influence — from batch record review to leading our eQMS modernization — in an environment that rewards initiative and systems-level thinking.What You'll DoLead failure investigations using root cause analysis tools (5-Why, Fishbone, FMEA) and drive CAPA implementationReview Batch Records, SOPs, and change controls for GDP compliance and regulatory alignmentEvaluate proposed process and design changes for change control requirements, guide qualification and validation criteriaMonitor and implement procedures related to Quarantine, Hold, Expired, Damaged, Return Goods, and Recalled productProvide routine analysis of KPIs and quality performance indicators; identify trendsSupport risk management file updates for process changes; implement process controls and error-proofing measuresCollaborate with functional process owners to train, mentor, and facilitate QMS requirements and continuous improvementSupport and administer eQMS modules CAPA, document control, deviation management, audit management, and training recordsContribute to eQMS upgrade, validation, and ongoing maintenance; support process, equipment, and method validation activities as required; ensure 21 CFR Part 11 compliance and audit trail integritySupport internal audit programs and assist in preparation for FDA, ISO, and customer auditsWhat You Bring7-9 years in a GMP-regulated environment pharma, personal care, or chemical manufacturingWorking knowledge of FDA 21 CFR 210/211, ISO 9001, ISO 22716, and 21 CFR Part 11Hands‑on experience with eQMS platforms (Veeva Vault, MasterControl, TrackWise, or similar)BA/BS in Engineering, Quality, Life Sciences, or related fieldHow We Measure SuccessGDP adherence on batch record and SOP reviews 98%eQMS module uptime and audit trail integrity 100%Internal audit findings closed within defined timelines 90%At least one eQMS process improvement or automation implemented By Month 9What We OfferCompetitive base salary commensurate with experienceMedical, dental, and vision insurance401(k) with company contributionPaid time off and holidaysApply TodayJoin a team where safety isn't a checkbox — it's a competitive advantage.Hubot, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.#J-18808-Ljbffr