Sr. Hardware Quality Engineer

As a Senior Hardware Quality Engineer at quip, you will be responsible for managing the end-to-end quality of the hardware products within quip's portfolio, including toothbrushes, flossers, and dispensers. The ideal candidate will have a proven track record in managing quality for both components and finished goods, with a deep understanding of materials and manufacturing processes. This hybrid role will require approximately three days a week at the headquarters in Dumbo, Brooklyn. The primary responsibilities include serving as the primary quality contact point, preventing customer satisfaction issues, establishing and ensuring conformance to engineering standards, and leading cross-functional problem-solving teams.

• Serve as the primary Quality contact point for both quality assurance and quality control for electronic and hardware product development through end of life
• Prevent customer satisfaction and durability issues by coordinating Failure Mode Effects Analysis (FMEA’s), product design specifications and tolerances reviews, past problem history, and supplier development.
• Establish and ensure conformance to engineering standards, product specifications, and highest customer expectations
• Develop and release product/process control plans, inspection standards, quality and testing plans and instructions, visual work instructions, technical specifications, and various manufacturing validations.
• Contain defective products through ownership of problem definition (8D’s), Root Cause Analysis (RCA’s), dispositions review, tracking of resolution effectiveness, and Containment coordination.
• Detect non-conformances and process variations through use and standardization of SPC systems, Change Control management, and both Internal auditing and Layered Process auditing.
• Lead cross-functional problem solving teams to drive process and product improvements; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions.
• Track and improve performance to internal and external quality performance metrics.
• Conducts investigations and Root Cause Analysis derived from Customer Complaints, RMAs, CAPAs, Manufacturing Process Data, Product Teardowns, and Field Audits
• Creates, edits and/or revises Test Method Validations, SOPs, WIs, and Product Specifications in support of continuous improvement.
• Accurately and thoroughly responds to customer requests for quality data or quality inquiries.
• Conducts employee training as required (i.e., GMP, Root Cause Analysis and best practices).
• Supports company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable FDA, ISO, and other regulatory requirements. Acts as a Quality ambassador for the company to promote Quality culture.
• Onboards and manages suppliers to quality performance targets; tracking and trending supplier performance with scorecards
• Support and monitor suppliers compliance to FDA requirements, ISO 13485, ISO 9001, etc.
• Provide input to the supplier selection process.

• 7+ years of experience in quality engineering or related field such as Engineering or Manufacturing
• Analytical curiosity and ability to solve complex problems using data
• Experience completing quality deliverables during new product development and into production
• Broad general mechanical and electrical engineering knowledge
• Working knowledge of some or all: ISO 13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR), ISO 9001
• Experience developing and implementing sampling plans, IQ/OQ/PQ, and process controls
• Six Sigma/Lean certification preferred
• Strong verbal and written communication skills, internal and external to the company
• Good interpersonal skills in dealing with a global supplier chain, peers and other functional areas
• Willing to travel domestically and internationally

• Competitive medical benefits, with 95% coverage for employees
• Free dental benefits for NYC residents
• Pre-Tax Commuter Benefits (~30% savings)
• Dependent care FSA
• Entire quip product line, refill plan, and employee discount
• $400 incentivized gym reimbursement through insurance
• Open Vacation Policy
• Computer and supplies provided
• Employee Assistance Program, including mental health resources
• Fully-stocked kitchen with kombucha, cold brew, and beer on tap
• Fun and inclusive culture with People Resource Groups and Interest Groups
• Team and company happy hours
• quip Swag
• Employee Referral Bonus Program
• Competitive paid parental leave policy
• Pet-friendly office
• Sequoia Smartspend, offering discounts on various products and services
• High potential for growth in a start-up atmosphere