At quip, we design and deliver delightful products and services that keep your mouth healthy.
As Manager, Compliance & Quality Systems on the Hardware Product Operations team, you will be responsible for developing and managing a robust Quality Systems as well as global compliance for quip’s product portfolio. This individual will be accountable for the implementation of new processes, standards, training, and auditing in support of new regulations and/or business objectives.
The ideal candidate would have experience with the development, implementation, and maintenance of Quality System Processes and representing Quality Systems & Compliance during inspections; ensuring Quality Systems are inspection ready and providing support for key inspection roles.
- Manage the quality systems to assure robust Quality Systems and compliance. Provide direction and support for the proactive development and implementation of Quality Systems improvements
- Provide regulatory guidance for new product development, product changes, and product market expansion
- Work to leadership to ensure alignment of global regulatory strategies with company objectives and implementation of the strategic plans
- Manage relationships with regulatory agencies across the world along with expert regulatory and legal consultants
- Manage the preparation, submission, and archival of all regulatory documentation
- Ensure an “inspection ready” state is maintained across all activities and the effectiveness of the internal audit program
- Facilitate management reviews of Quality Systems performance and internal audits
- Organize and assist with the execution of risk assessments on equipment, assembly process, supply chain, and customer use case to comply with industry and regulatory standards
- Ownership of the Quality Management System (QMS) that includes: Deviation, Complaints, Investigations, CAPA, Quality Risk Management, Quality Management Review, Training, Change Management, Document Management, Data Integrity, Supplier Quality Management, Compliance/Auditing
- Provide guidance for regulatory marking and documentation requirements on products and packaging, examples include FCC, UL, CE, RoHS, WEEE, REACH for both safety and EMC/EMI
- Influence all levels of the organization and regulatory bodies. Present both verbally and orally as needed. Includes presentations to upper management, training, audits presentations, business communications, investigation summaries, and audit reports
- 5+ years experience managing Quality Systems, US and/or global compliance for regulated consumer electronic medical devices and/or consumable/OTC products
- Experience working with Product Development, Engineering, Operations, and Marketing to establish regulatory and compliance strategies for new products and countries/markets
- Expert knowledge of all or some - cGMP, ISO 9001, ISO 13485, MDSAP, 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
- Experience/knowledge with change controls, validations, and IQ/OQ/PQ to make the final decision on requirements needed to implement a change.
- Quality Systems development and auditing experience
- Knowledge of regulatory compliance standards and regulatory filings
- Strong facilitation skills and advanced understanding of project management
- Strong understanding of Data Integrity requirements and application at local site and global network
- Excellent interpersonal, communication and presentation skills, ability to work in multinational environments, driven and motivated by accomplishing world-class objectives
- 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
- 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.