DESCRIPTIONAs 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.
This role is
full time on-site Monday-Thursday in our DUMBO, Brooklyn design studio, with Fridays remote.
Base Salary: $150k-$165KThis 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.
Work 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.
RESPONSIBILITIESRegulatory & Safety- Ensure all quip products comply with relevant legal and regulatory requirements
- Own and maintain the regulatory matrix across current and future expansion markets
- Own development of regulatory markings, serialization, and product safety/warning language across printed and digital materials
- Ensure product claims are substantiated by the engineering/product team and aligned with marketing needs; facilitate third-party testing when necessary
- Own regulatory portals (Intertek, WercSmart, Bluetooth SIG, FDA, etc.) and act as point person to keep information current and retrievable
FDA Compliance & Reporting- Own quip's end-to-end FDA compliance program for its Class I devices
- Own US FDA Medical Device Reporting (MDR) compliance
- Maintain quip's FDA complaint file (21 CFR 820.198)
- Own UDI/GUDID compliance - ensure device labeling carries required unique device identifiers and that device data is submitted and maintained in FDA's GUDID database
- Confirm and own quip's own FDA establishment registration and device listing (21 CFR Part 807), independent of any registration maintained by contract manufacturers
Supplier Governance- Audit and oversee contract manufacturers' Quality Management Systems for strict adherence to ISO 13485 and ISO 9001
- Own and manage the CAPA and deviation processes
- Conduct supplier audits and track CM performance systemically
- Audit new suppliers as needed
New Product Development- Serve as the required quality sign-off in new product development
- Ensure records are complete and defensible before launch
Risk Management- Own quip's Risk Management File incorporating FMEA analysis from Product Quality Engineering
- Confirm residual risks are actually acceptable and properly controlled before sign-off
Validation & Test Planning- Provide final regulatory sign-off on new product Design and Manufacturing Validation test plans and reports, following Product Quality Engineering's technical sign-off
- Ensure validation documentation meets quality, safety, and regulatory requirements and is defensible for compliance purposes
Sensitive Issue Escalation- Act as the escalation point for sensitive CX issues
- Escalate to leadership and legal when necessary
- Partner with CX and Marketing to develop appropriate responses to sensitive issues
Internal Process Improvement- Identify gaps in quip's internal quality or regulatory processes
- Develop SOPs where needed
- Roll out and train the team on new processes
Document Control- Manage the routing, approval, and archiving of critical documents
- Ensure the quip team consistently follows document organization, storage, and retention protocols
REQUIREMENTS- 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.
- Familiarity 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
- High cavitation injection molding and machining process experience
- Strong communication skills to present quality risks to executive leadership
- Ability to travel internationally 2-3 times per year to be on-site at suppliers
- Ability to attend evening calls with suppliers 1-2 nights per week
- Bachelor's (B.S.) or Masters Degree in Mechanical or Biomedical Engineering
NICE TO HAVES:- Experience with IPX rated products that require defense against moisture ingress
- Experience with FDA regulations for dietary supplements or OTCs
- Experience with FDA, ADA, WERC account ownership
- Experience working with Asian suppliers and contract manufacturers
Benefits- Hybrid working environment, with an office located in the heart of DUMBO with breathtaking views of Manhattan Bridge
- Year round early "summer Fridays"
- WiFi enabled rooftop
- Competitive medical benefit package
- Commuter benefits for parking & transit
- Competitive paid parental leave policy for qualifying employees
- Open vacation policy
- Dog-friendly office space
- 401k Tax Benefits
- Competitive compensation package
- Fully stocked kitchen with snacks (make sure to use your quip after snacking!)
- Your very own quip with employee discount packages
- The opportunity to help us make oral care more simple, effective and accessible!
}
