At quip, we design and deliver delightful products and services that keep your mouth healthy.
As a Consumables Quality Engineer on the Hardware Product Operations team, you will be responsible for managing end-to-end quality of the consumables (i.e. toothpaste, gum, mouthwash, etc.) within quip’s product portfolio.
The ideal candidate would have a proven track record in managing both component and finished goods supplier quality, as well as experience working in a regulated environment. This role requires an in-depth understanding of materials, manufacturing processes, and significant experience in quality management in a regulated environment. Data analysis and reporting skills are critical to this role.
- Be the lead Quality contact point for consumable products from development through production
- Plans, organizes, directs and reports on all Quality related activities for components, contract manufactured items, and packaging materials
- Apply sound, systematic problem-solving methodologies, including but not limited to six sigma tools, in identifying, prioritizing, communicating, and resolving quality issues
- Ensure suppliers are compliant with FDA requirements, ISO 13485, ISO 9001- Interface with suppliers regarding quality issues on consumables suppliers and establish internal and external quality processes
- Identify and implement effective process control systems to support the development, qualification, product transfers and on-going manufacturing of consumables to meet or exceed internal and external requirements
- Create and roll out process controls systems for consumables designed to meet internal and external requirements
- Identify and own internal and external quality engineering initiatives as they pertain to consumables
- Lead investigations for quality excursions using CAPA, 8D, and other tools
- Support on-site/off-site supplier quality development
- Lead quality system audits and manage improvements
- Onboards and manage suppliers to quality performance targets; tracking and trending supplier performance with scorecards
- Provides input to the supplier selection process for the quality items
- 3+ years of experience in quality engineering, preferable in food, cosmetic, OTC drug, or pharmaceutical environments
- Experience working in a regulated environment
- Analytical curiosity and ability to solve complex problems using data
- Experience with consumable product development, testing, qualifications, and production
- 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), FDA FCS
- 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 supply chain, peers and other functional areas
- Willing to travel within North America and potentially other global locations
- You'll be working in a high energy, fast-paced environment helping us make oral care simple and effective!
- An office located in the heart of DUMBO with breathtaking views of Manhattan Bridge (the office is currently remote in response to COVID-19)
- WiFi enabled rooftop
- Competitive medical benefit package (with an option to opt into a premium internal dental program)
- Commuter benefits for parking & transit
- Offer competitive paid parental leave policy for qualifying employees
- Flexible work from home options
- Open vacation policy
- Dog-friendly office space
- 401k Contribution
- 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!
Most of us aren’t brushing our teeth correctly, either because we don’t know how to do it right, or because we just don’t feel like it. At quip, we design delightful products and experiences to help you care for your mouth better. Our initial product is a beautifully simple electric toothbrush and toothpaste that was featured by Time Magazine as one of the 25 Best Inventions of 2016. With refill brush heads and toothpaste arriving on a 3-monthly schedule. We pride ourselves on great design and our brand values of simplicity, honesty, and accessibility, which are applied throughout our community. We are excited to apply these principles to the acceleration of our digital patient-professional advice and services platform.
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.