Senior Quality Systems & Regulatory Engineer

Overview

quip is a design-led oral health and wellness company that launched in 2015. The company aims to change oral care habits from a have-to chore to a want-to ritual. quip creates bold, simple, design-driven products that are backed by science and intuitive to use, empowering people to make their mouth part of their daily wellness routine. quip’s current personal care offerings include ADA-accepted adult and kid electric toothbrushes, smart brushes, rechargeable water flosser, refillable floss string, refillable gum and mints.

All products are designed to help people build good oral care habits. quip is an omni-channel business with strength in DTC, Retail, Amazon and Dental Professional DTC channels.

As the Senior Quality, Regulatory & Systems Engineer, you are the strategic lead for quip’s product integrity. You own the systems that tell us how our products are performing in the real world. By managing CX data and RMA trends, you provide the "marching orders" for the engineering team. You also protect the brand by managing our global supplier quality (SQE) and ensuring we remain fully compliant with FDA and ISO standards.

This role is full time on-site in our DUMBO, Brooklyn design studio.

Base Salary: $135k-$165k. This range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). Compensation may vary based on location, role-related knowledge, experience and skills.

• Quality Data & Systems:
  Own the "Single Source of Truth" for quality. Manage the ingestion of CX/RMA data, build reporting dashboards, and provide data-driven direction on where to focus engineering investigations.
• Strategic Prioritization:
  Based on data trends, provide direction to the engineering team on which improvements are most critical for the business.
• Sustainability & Environmental Compliance:
  Manage global compliance requirements including RoHS, REACH, and sustainable packaging certifications.
• Regulatory & Safety:
  Lead FDA Class I/II filings and maintain the Quality Management System (QMS) in accordance with ISO 13485 and 9001. Lead master Risk Management and FMEA files.
• Supplier Governance (SQE):
  Conduct system-level supplier audits and manage the Supplier Scorecard system to track systemic CM performance.
• Validation & Test Planning:
  Vet and sign off on Master Validation Plans and IQ/OQ/PQ protocols for internal labs and Contract Manufacturers (CMs). Ensure all validation is audit-proof for regulatory bodies.
• Reliability & Lifecycle Testing:
  Own the Reliability testing program. Define ORT requirements for factory partners and monitor long-term durability and wear trends.
• Document Control & PLM:
  Act as the gatekeeper for quip’s Product Lifecycle Management (PLM). Manage routing, approval, and archiving of critical documents.
• Risk Management:
  
  Own the master Risk Management files and high-level FMEA documentation. Participate and sign off in new product development.

• 4+ years in Quality Engineering or Quality Systems management
• 8+ years experience working in new product development with Asian suppliers and contract manufacturers with a focus on high-volume electronic consumer products
• Expertise in Data Management (Excel, SQL, or Tableau) to visualize quality trends
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 or demonstrated ability to learn and lead compliance to these standards
• High cavitation injection molding and machining process experience
• Deep knowledge of materials, processes, assembly, electronics, and production methods
• 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 or Master’s Degree in Mechanical or Biomedical Engineering

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

• Hybrid working environment, with an office located in the heart of DUMBO with views of Manhattan Bridge
• Year-round early "summer…