Senior Quality Systems & Regulatory Engineer

quip•New York, NY

9d•$135,000 - $165,000•Onsite

About The Position

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.

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

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.

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!