Sr. Regulatory & Quality Systems Engineer

quip•New York, NY

1d•$150,000 - $165,000•Hybrid

About The Position

As 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.

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

Responsibilities

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
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
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
Serve as the required quality sign-off in new product development
Ensure records are complete and defensible before launch
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
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
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
Identify gaps in quip's internal quality or regulatory processes
Develop SOPs where needed
Roll out and train the team on new processes
Manage the routing, approval, and archiving of critical documents
Ensure the quip team consistently follows document organization, storage, and retention protocols

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!