Quip is real-time collaborative documents, spreadsheets, and chat embedded inside Salesforce to transform any business process. Backed by Greylock.
About the role
As Sr. Regulatory & Quality Systems Engineer, you are the strategic lead for quip's product integrity — the person who ensures every product we ship is safe, compliant, and defensible, from first regulatory filing through post-market surveillance. You'll own our regulatory strategy across current and future markets, govern our contract manufacturers' quality systems, and act as the sign-off authority in new product development.
What they're looking for
- 6+ years experience in Regulatory and/or Quality Engineering / Systems management Knowledge of FDA 21 CFR Part 820 and ISO 13485 or demonstrated ability to learn and lead compliance to these standards
- Familiarity with FDA Medical Device Reporting (21 CFR Part 803), UDI/GUDID (21 CFR Part 830), and establishment registration & listing (21 CFR Part 807) for Class I devices
- High cavitation injection molding and machining process experience
- Strong communication skills to present quality risks to executive leadership
- Ability to travel internationally 2-3 times per year to be on-site at suppliers
- Ability to attend evening calls with suppliers 1-2 nights per week
More about this role
As Sr. Regulatory & Quality Systems Engineer, you are the strategic lead for quip's product integrity — the person who ensures every product we ship is safe, compliant, and defensible, from first regulatory filing through post-market surveillance. You'll own our regulatory strategy across current and future markets, govern our contract manufacturers' quality systems, and act as the sign-off authority in new product development. This role suits someone who thinks in systems and audit trails as naturally as they think in root causes, and who's ready to build (not just maintain) quip's regulatory and quality infrastructure as we expand into new categories and markets. You will report into the Hardware team but also have accountability into the Consumables Lead day-to-day.
This role is full time on-site Monday–Thursday in our DUMBO, Brooklyn design studio, with Fridays remote.
This range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). We carefully assess and consider several factors with each candidate, including location, role-related knowledge, experience and skills. Compensation may vary based on these...
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