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← QUIP

Sr. Regulatory & Quality Systems Engineer

QUIP
Location
quip NYC
Posted
11 days ago
Department
Technology
Salary
$150k-$165K
What they actually want (must-haves)
  • 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
Nice to have
  • 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
What the job really is

As a Sr. Regulatory & Quality Systems Engineer at quip, you will lead the regulatory strategy for product integrity, ensuring compliance and safety from initial filings to post-market surveillance. Your responsibilities include managing FDA compliance for Class I devices, overseeing contract manufacturers' quality systems, and serving as the quality sign-off authority in new product development. This role requires a strategic mindset to build and enhance quip's regulatory and quality infrastructure as the company expands into new markets.

Benefits
  • Hybrid working environment, with an office located in the heart of DUMBO with breathtaking views of Manhattan Bridge
  • Year round early “summer Fridays”
  • WiFi enabled rooftop
  • Competitive medical benefit package
  • Commuter benefits for parking & transit
  • Competitive paid parental leave policy for qualifying employees
Things to weigh
  • Full-time on-site Monday–Thursday with remote work on Fridays
  • No salary listed beyond the range of $150k-$165K
  • Position not eligible for immigration sponsorship
  • Role involves significant responsibility in regulatory compliance and quality systems management
Job score4.8/5
Benefits5/5
Freshness5/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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