Hardware Quality Engineer
Posted on 4/4/2023
INACTIVE
quip

51-200 employees

Direct-to-consumer oral care subscription service
Company Overview
quip is a pioneer in the oral care industry, offering a unique direct-to-consumer subscription service that delivers fresh oral care supplies every three months, making oral health more accessible and enjoyable. The company stands out for its commitment to customer service, guaranteeing all products for life and providing a responsive help platform. Furthermore, quip is developing a bidirectional tech platform to connect users with a large dental professional network, demonstrating its dedication to improving the overall oral care experience.
Consumer Goods
Hardware
B2C

Company Stage

Series B

Total Funding

$205.8M

Founded

2014

Headquarters

Brooklyn, New York

Growth & Insights
Headcount

6 month growth

-6%

1 year growth

-22%

2 year growth

-22%
Locations
New York, NY, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • 5+ 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
Responsibilities
  • 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