At quip, we design and deliver delightful products and services that keep your mouth healthy.
As the Director of Quality and Compliance on the Product Operations Team, you will own product quality, product compliance, and regulatory compliance, including reliability, process quality, supplier quality, product compliance, and regulatory compliance for medical devices and oral healthcare consumable products. The Product Quality and Compliance Director is responsible for improving & driving a culture of total quality and compliance. A thorough understanding of Global Market compliance requirements is required.
The ideal candidate would have extensive experience with product reliability, factory quality, supplier quality, compliance for consumer medical device hardware that is manufactured in ISO 13485 and GMP compliant facilities, and continuous improvement programs such as Kaizen and Six Sigma.
- Accountable for Quality System personnel and maintenance of Quality owned Quality Management System and Processes (Deviation, Complaints, Investigations, CAPA, Quality Risk Management, Quality Management Review, Training, Change Management, Document Management, Data Integrity, Supplier Quality Management, Compliance/Auditing, and implementing APQP principles)
- Develop and nurture core competencies within Quality and Compliance to build a high performing team. Provide medium and long-range career development plans that provide new opportunities, challenges, and growth. Proactively identify and implement continuous improvement opportunities and initiatives
- Manage interactions and relationships with auditors and regulators and participate in regulatory inspection preparations and execution of inspections
- Remain abreast of current regulations and industry best practices.
- Ensures the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization and drives organizational accountability for quality between Sourcing, Manufacturing, Supplier Management, Product Engineering, and Customer Service
- Promotes a risk-based approach to Failure Analysis, the handling of Quality Events, Process Implementation, Process Improvements, and implement a predictive validity approach to reliability testing.
- Ensure product development follow QMS processes and ISO 13485 compliant manufacturing lines are designed and deployed during the NPI phase and to produce quality products efficiently during mass production.
- Proven leadership skills – building teams, leading other leaders, coaching, and development of others providing both tactical and strategic leadership to an organization
- Minimum of 10 years of professional experience with progressive experience in Quality, Operations, and Manufacturing Engineering
- Strong hands-on management and leadership experience in product quality, including: reliability, process quality, supplier quality, and compliance in an ISO 13485 compliant medical device manufacturing and supply chain environment
- Working knowledge of FDA 21 CFR part 820.
- Performs QA oversight of supplier audits, qualification and quality agreement; when needed, partner with operations and supply chain management in addressing supplier quality issues
- Deep understanding and appreciation for regulatory requirements and compliance standards governing medical devices
- Proven track record in change management, positive influencing, and conflict resolution
- Data-driven, decisive, and goal-oriented
- 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
- Fully covered health insurance (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
- Extended Education Assistance
- Employee Referral Program
- Competitive compensation package with stock options at a high-growth startup
- Fully stocked kitchen with snacks (make sure to use your quip after snacking!)
- Generous employee discount on all quip products
- 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 are now growing our product line with that same standard of design. We pride ourselves on great design and our brand values of simplicity, honesty and accessibility are applied throughout our community.
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.