Sr. Regulatory & Quality Systems Engineer

Own quip's end-to-end FDA compliance program for its Class I devices

Own US FDA Medical Device Reporting (MDR) compliance

Maintain quip's FDA complaint file (21 CFR 820.198)

Own UDI/GUDID compliance — ensure device labeling carries required unique device identifiers and that device data is submitted and maintained in FDA's GUDID database

Confirm and own quip's own FDA establishment registration and device listing (21 CFR Part 807), independent of any registration maintained by contract manufacturers

Audit and oversee contract manufacturers' Quality Management Systems for strict adherence to ISO 13485 and ISO 9001

Own and manage the CAPA and deviation processes

Conduct supplier audits and track CM performance systemically

Audit new suppliers as needed

Serve as the required quality sign-off in new product development

Ensure records are complete and defensible before launch

Own quip's Risk Management File incorporating FMEA analysis from Product Quality Engineering

Confirm residual risks are actually acceptable and properly controlled before sign-off

Provide final regulatory sign-off on new product Design and Manufacturing Validation test plans and reports, following Product Quality Engineering's technical sign-off

Ensure validation documentation meets quality, safety, and regulatory requirements and is defensible for compliance purposes

Act as the escalation point for sensitive CX issues

Escalate to leadership and legal when necessary

Partner with CX and Marketing to develop appropriate responses to sensitive issues

Identify gaps in quip's internal quality or regulatory processes

Develop SOPs where needed

Roll out and train the team on new processes

Manage the routing, approval, and archiving of critical documents

Ensure the quip team consistently follows document organization, storage, and retention protocols

Experience with IPX rated products that require defense against moisture ingress

Experience with FDA regulations for dietary supplements or OTCs

Experience with FDA, ADA, WERC account ownership

Experience working with Asian suppliers and contract manufacturers

quip is a design-led oral health and wellness company on a mission to transform oral care from a "have-to" chore into a "want-to" ritual. Launched in 2015, we provide effective, simple and well-designed oral health products with electric toothbrushing at the center. Our award-winning product lineup includes sonic and oscillating toothbrushes, smart brushes that track habits, water flossers, and refillable essentials like floss, and whitening strips. Our products are available for subscription on our site as well as on Amazon, in most major retailers and for sale to Dental Offices.

quip empowers millions of users to take proactive control of their oral health. We believe that by combining science-backed design with intuitive technology, we can guide a lifetime of better habits for every mouth. At quip, we work as one team, stay agile, bring positive energy to everything we do, and play to win for our customers and each other.

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.