Sr. Quality Systems & Regulatory Engineer

Location: quip NYC

Department: Hardware

DESCRIPTION

quip is a design-led oral health and wellness company that launched in 2015 and is on mission 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, which empower everyone to proactively make their mouth part of their daily wellness routine. quip's current personal care offerings include the American Dental Association accepted (ADA seal) 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 a truly 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). 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: 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, you provide direction to the engineering team 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 both internal labs and Contract Manufacturers (CMs). Ensure all validation is "audit-proof" for regulatory bodies.
• Reliability & Lifecycle Testing: Own the Reliability testing program. Define Ongoing Reliability Testing (ORT) requirements for factory partners and monitor long-term durability and "wear and tear" trends.
• Document Control & PLM: Act as the gatekeeper for quip’s Product Lifecycle Management (PLM). Manage the routing, approval, and archiving of critical documents.
• Risk Management: Own the master Risk Management files and high-level FMEA (Failure Mode and Effects Analysis) documentation. Participate and sign off in new product development.

REQUIREMENTS

• 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 (B.S.) or Masters Degree in Mechanical or Biomedical Engineering

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 (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!

About quip

quip is a design-led oral health and wellness company on a mission to transform oral care from a "have-to" chore into a "want-to" ritual. Launched in 2015, we provide effective, simple and well-designed oral health products with electric toothbrushing at the center. Our award-winning product lineup includes sonic and oscillating toothbrushes, smart brushes that track habits, water flossers, and refillable essentials like floss, and whitening strips. Our products are available for subscription on our site as well as on Amazon, in most major retailers and for sale to Dental Offices.

quip empowers millions of users to take proactive control of their oral health. We believe that by combining science-backed design with intuitive technology, we can guide a lifetime of better habits for every mouth. At quip, we work as one team, stay agile, bring positive energy to everything we do, and play to win for our customers and each other.

quip is committed to promoting equality, inclusion, and diversity beyond your brushing routine. We believe our company is better equipped to care for every mouth when we listen to fresh perspectives from every voice, and in doing so, we build an equal-opportunity team of the brightest minds (and mouths)—regardless of race, gender, age, religion, sexual orientation, identity, or any other trait that makes you you. By celebrating and supporting our differences, we will thrive in our mission to improve oral health for all.