At quip, we design and deliver delightful products and services that keep your mouth healthy.
As the Director of Manufacturing and Quality on the Product Operations Team, you will own manufacturing engineering and product quality, including; reliability, process quality, supplier quality, and compliance. The Product Quality Director is responsible for improving & driving a culture of total quality and lean manufacturing.
The focus of this role will be on enhancing our ability to bring the best, FDA compliant, products to market meeting stringent quality standards through the delivery of best in class manufacturing and quality processes. Develop strategies, based on best practices, around manufacturing and quality management to support the company’s entire product portfolio of CE medical devices and consumables. This role will collaborate closely with Product Managers, Customer Service, Product Engineering, Sourcing, NPI, and Supply Chain. You will be responsible for the leadership of the team and will be expected to establish goals and to deliver objectives while fostering the growth of the team members in a fast-paced environment.
The ideal candidate would have extensive experience with Lean Manufacturing, manufacturing test, reliability, factory quality, supplier quality, compliance for consumer hardware that is manufactured in ISO 13485 compliant facilities, and continuous improvement programs such as Kaizen and Six Sigma. This candidate would also have experience in Medical Devices, Plastic Injection Molding, SMT Technology, and working closely with overseas contract manufacturers.
- Build, grow, inspire and coach a high performing team that is capable of meeting/exceeding business goals and objectives. Assess current organizational capability to understand gaps and devise plans to close those gaps through hiring, training, and coaching/mentoring. Develop and nurture core competencies within Manufacturing and Quality 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
- Accountable for Quality System personnel and implementation and maintenance of Quality owned Quality System 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)
- Responsible for the direct supervision, coaching, and development of the Manufacturing Engineering, Reliability, Quality System, and Compliance Management team
- Maintain and grow high levels of organizational accountability for quality between Supplier Management, Product Engineering, and Customer Service
- Ownership of the Quality Management System (QMS), managing the implementation and execution of the QMS and ensuring alignment to current regulations. Identify and address gaps related to all aspects of product quality, including opportunities for ongoing innovation and improvements
- Develop a robust supplier qualification and classification system
- Deviation/Investigation/CAPA Management to drive continuous supplier improvement and to ensure product quality
- 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
- Participate in regulatory inspection preparations and execution of inspections
- Remain abreast of current regulations and industry best practices, ensuring compliant products are developed and manufactured
- Drive the investigation of product, component, and/or material issues or supply constraints and assist with troubleshooting remotely and/or on-site at the manufacturing facilities
- Lead the team in problem-solving and process/system improvement using yield improvement studies, GR&R, Lean Six Sigma, and Design of Experiments to optimize manufacturing processes at CMs and up-stream suppliers
- Ensure the completion of thorough First Articles, process qualifications, PFMEA, DOEs, and engineering change requests
- Ensure product development processes are followed and manufacturing lines are developed and deployed during the NPI phase to produce quality products efficiently during mass production, meeting output and yield targets
- Oversee the develop new manufacturing processes, system infrastructure, jigs and fixture to deliver low cycle time and high-quality output at a stable and predictable rate to deliver to product requirements and business needs
- Proven leadership skills – building teams, leading other leaders, coaching, and development of others providing both tactical and strategic leadership to an organization
- 5 + years of professional experience with progressive experience in Quality, Operations, and Manufacturing Engineering
- Strong hands-on management and leadership experience in manufacturing engineering and product quality, including reliability, process quality, supplier quality, and compliance in an ISO 13485 compliant medical device manufacturing and supply chain environment
- Strong knowledge of materials, product design, fabrication, assembly, test, tooling, and automation
- 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
- Startup experience is a plus
- 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
- 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 Support
- Employee Referral Bonus
- Competitive compensation package with stock options at a high-growth startup
- Fully stocked kitchen with snacks (make sure to use your quip after snacking!)
- Your very own quip with an unlimited subscription plan
- 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.