Quality Systems & Regulatory Engineer

DESCRIPTION

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.

 

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.

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

 

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 (m