{"id":807265,"url":"https://alion.io/job/quip-sr-regulatory-quality-systems-engineer","title":"Sr. Regulatory & Quality Systems Engineer","company":{"id":174510,"name":"quip","domain":"getquip.com","url":"https://alion.io/company/quip-2","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["New York, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":165000,"currency":"USD","period":"year","gross":null,"usd_annual":165000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Wi-Fi","optional":true}],"status":"live","first_seen_at":"2026-09-09T19:34:46Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-11-01T09:02:29Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"description":"DESCRIPTION\nAs Sr. Regulatory & Quality Systems Engineer, you are the strategic lead for quip's product integrity - the person who ensures every product we ship is safe, compliant, and defensible, from first regulatory filing through post-market surveillance. You'll own our regulatory strategy across current and future markets, govern our contract manufacturers' quality systems, and act as the sign-off authority in new product development. This role suits someone who thinks in systems and audit trails as naturally as they think in root causes, and who's ready to build (not just maintain) quip's regulatory and quality infrastructure as we expand into new categories and markets. You will report into the Hardware team but also have accountability into the Consumables Lead day-to-day.\nThis role is full time on-site Monday-Thursday in our DUMBO, Brooklyn design studio, with Fridays remote.\nBase Salary: $150k-$165K\nThis range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). We carefully assess and consider several factors with each candidate, including location, role-related knowledge, experience and skills. Compensation may vary based on these considerations.\nWork Authorization: This position is not eligible for immigration sponsorship. Applicants must be currently authorized to work in the United States and must not require quip to initiate, transfer, maintain, extend, or otherwise support an employment-based immigration status now or in the future. This includes employer action related to a change or transfer of sponsoring employer.\nRESPONSIBILITIES\nRegulatory & Safety\nEnsure all quip products comply with relevant legal and regulatory requirements\nOwn and maintain the regulatory matrix across current and future expansion markets\nOwn development of regulatory markings, serialization, and product safety/warning language across printed and digital materials\nEnsure product claims are substantiated by the engineering/product team and aligned with marketing needs; facilitate third-party testing when necessary\nOwn regulatory portals (Intertek, WercSmart, Bluetooth SIG, FDA, etc.) and act as point person to keep information current and retrievable\nFDA Compliance & Reporting\nOwn quip's end-to-end FDA compliance program for its Class I devices\nOwn US FDA Medical Device Reporting (MDR) compliance\nMaintain quip's FDA complaint file (21 CFR 820.198)\nOwn UDI/GUDID compliance - ensure device labeling carries required unique device identifiers and that device data is submitted and maintained in FDA's GUDID database\nConfirm and own quip's own FDA establishment registration and device listing (21 CFR Part 807), independent of any registration maintained by contract manufacturers\nSupplier Governance\nAudit and oversee contract manufacturers' Quality Management Systems for strict adherence to ISO 13485 and ISO 9001\nOwn and manage the CAPA and deviation processes\nConduct supplier audits and track CM performance systemically\nAudit new suppliers as needed\nNew Product Development\nServe as the required quality sign-off in new product development\nEnsure records are complete and defensible before launch\nRisk Management\nOwn quip's Risk Management File incorporating FMEA analysis from Product Quality Engineering\nConfirm residual risks are actually acceptable and properly controlled before sign-off\nValidation & Test Planning\nProvide final regulatory sign-off on new product Design and Manufacturing Validation test plans and reports, following Product Quality Engineering's technical sign-off\nEnsure validation documentation meets quality, safety, and regulatory requirements and is defensible for compliance purposes\nSensitive Issue Escalation\nAct as the escalation point for sensitive CX issues\nEscalate to leadership and legal when necessary\nPartner with CX and Marketing to develop appropriate responses to sensitive issues\nInternal Process Improvement\nIdentify gaps in quip's internal quality or regulatory processes\nDevelop SOPs where needed\nRoll out and train the team on new processes\nDocument Control\nManage the routing, approval, and archiving of critical documents\nEnsure the quip team consistently follows document organization, storage, and retention protocols\nREQUIREMENTS\n 6+ years experience in Regulatory and/or Quality Engineering / Systems management Knowledge of FDA 21 CFR Part 820 and ISO 13485 or demonstrated ability to learn and lead compliance to these standards.\nFamiliarity with FDA Medical Device Reporting (21 CFR Part 803), UDI/GUDID (21 CFR Part 830), and establishment registration & listing (21 CFR Part 807) for Class I devices\nHigh cavitation injection molding and machining process experience\nStrong communication skills to present quality risks to executive leadership\nAbility to travel internationally 2-3 times per year to be on-site at suppliers\nAbility to attend evening calls with suppliers 1-2 nights per week\nBachelor’s (B.S.) or Masters Degree in Mechanical or Biomedical Engineering\nNICE TO HAVES:\nExperience with IPX rated products that require defense against moisture ingress\nExperience with FDA regulations for dietary supplements or OTCs\nExperience with FDA, ADA, WERC account ownership\nExperience working with Asian suppliers and contract manufacturers\nBenefits\nHybrid working environment, with an office located in the heart of DUMBO with breathtaking views of Manhattan Bridge\nYear round early “summer Fridays”\nWiFi enabled rooftop\nCompetitive medical benefit package\nCommuter benefits for parking & transit\nCompetitive paid parental leave policy for qualifying employees\nOpen vacation policy\nDog-friendly office space\n401k Tax Benefits\nCompetitive compensation package\nFully stocked kitchen with snacks (make sure to use your quip after snacking!)\nYour very own quip with employee discount packages\nThe opportunity to help us make oral care more simple, effective and accessible!\nAbout quip\nquip is a design-led oral health and wellness company on a mission to transform oral care from a \"have-to\" chore into a \"want-to\" ritual. Launched in 2015, we provide effective, simple and well-designed oral health products with electric toothbrushing at the center. Our award-winning product lineup includes sonic and oscillating toothbrushes, smart brushes that track habits, water flossers, and refillable essentials like floss, and whitening strips. Our products are available for subscription on our site as well as on Amazon, in most major retailers and for sale to Dental Offices.\nquip empowers millions of users to take proactive control of their oral health. We believe that by combining science-backed design with intuitive technology, we can guide a lifetime of better habits for every mouth. At quip, we work as one team, stay agile, bring positive energy to everything we do, and play to win for our customers and each other.\nquip is committed to promoting equality, inclusion, and diversity beyond your brushing routine. We believe our company is better equipped to care for every mouth when we listen to fresh perspectives from every voice, and in doing so, we build an equal-opportunity team of the brightest minds (and mouths)-regardless of race, gender, age, religion, sexual orientation, identity, or any other trait that makes you you. 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