Quality Systems & Regulatory Engineer

quip•New York, NY

12h•$125,000 - $145,000•Onsite

About The Position

quip is a design-led oral health and wellness company that launched in 2015 with a mission to change oral care habits from a have-to chore into a want-to ritual. quip creates bold, simple, design-driven products backed by science and intuitive to use, empowering people to make oral care part of their daily wellness routine. quip is a truly omni-channel business with strength in DTC, Retail, Amazon, and Dental Professional channels. As a Quality Systems & Regulatory Engineer, you will play a key role in supporting product integrity across quip’s portfolio. You will work closely with engineering, operations, and external partners to monitor product performance, support quality systems, and ensure compliance with regulatory standards. This role is ideal for someone with a strong foundation in quality and regulatory work who is looking to deepen their experience in quality systems, data analysis, and cross-functional collaboration. This role is full time on-site in our DUMBO, Brooklyn design studio. Base Salary: $125k-$145K This 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.

Requirements

3+ years of experience in Quality Engineering or Quality Systems
Experience working in new product development and/or with suppliers or contract manufacturers
Exposure to quality systems, regulatory environments, or compliance frameworks (FDA, ISO, etc.)
Experience or familiarity with data analysis tools (Excel, Looker, SQL, Python, or similar)
Foundational knowledge of materials, manufacturing processes, or product development
Strong communication skills and ability to work cross-functionally
Willingness to travel internationally 2–3 times per year
Ability to attend weekly evening calls with global suppliers
Bachelor’s degree in Mechanical, Biomedical, or related Engineering field

Nice To Haves

Solidworks CAD experience
Experience with motors
Experience with IPX rated products that require defense against moisture ingress
Experience with FDA, ADA, WERC account ownership

Responsibilities

Quality Data & Systems: Support the management of quality data systems, including CX and RMA data. Help analyze trends and contribute to reporting that informs engineering investigations and product improvements.
Data-Driven Insights: Partner with the engineering team to identify trends and areas for improvement based on quality data.
Sustainability & Environmental Compliance: Support global compliance efforts, including RoHS, REACH, and sustainable packaging initiatives.
Regulatory & Safety: Support FDA Class I filings and contribute to maintaining the Quality Management System (QMS) in accordance with ISO 13485 and 9001.
Supplier Quality (SQE): Assist in supplier quality activities, including audits, performance tracking, and maintaining supplier scorecards.
Validation & Test Planning: Contribute to validation planning and documentation (IQ/OQ/PQ), ensuring alignment with internal and regulatory standards.
Reliability & Lifecycle Testing: Support reliability testing programs, including monitoring product durability and performance over time.
Document Control & PLM: Support PLM processes, including document routing, approvals, and maintaining accurate records.
Risk Management: Contribute to Risk Management and FMEA documentation and participate in new product development activities.

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!