Demo

Manager - Quality and Regulatory

CUATTRO IMAGING, LLC
Denver, CO Full Time
POSTED ON 4/4/2025
AVAILABLE BEFORE 6/3/2025

Team: Quality & Compliance

Reports To: COO

About Us

Our company is a highly mobile and innovative group of people that builds advanced digital radiography (X-ray) imaging systems used in medical diagnostics, global security/military, and industrial non-destructive testing (NDT). Whether it’s helping doctors make critical decisions, protecting borders, or inspecting pipelines and welds—our tech is designed for precision, reliability, and safety.

As we grow, we’re looking for someone to take ownership of quality and regulatory compliance across all these sectors. If you're comfortable switching between startup agility and regulatory rigor with a hyperactive team then you’ll fit right in.

What You’ll Do

  • Own and run our Quality Management System (QMS) — making sure it supports both compliance and speed.
  • Drive regulatory strategy and execution across medical (FDA, ISO 13485), industrial (ASME, API), and security (MIL) verticals.
  • Manage certifications, filings, audits, and documentation—staying a few steps ahead of what regulators need.
  • Be the go-to expert on FDA, ISO, ASME, API, and more—guiding design, manufacturing, and field teams through what’s required.
  • Work cross-functionally with engineering, product, ops, and leadership to keep quality and compliance embedded in everything we build.
  • Support internal audits, supplier audits, and product testing (incoming and outgoing) from a quality perspective.
  • Continuously improve our systems and processes—automating and simplifying wherever possible.

What We’re Looking For

Must-haves:

  • 3 years of experience in quality and regulatory roles, ideally with both hardware and software products and hands on experience with filings, regulatory clearance and submission processes, and audits.
  • Solid working knowledge of FDA 21 CFR Part 820, ISO 13485 / 9001, ASME Section V, API, MIL and CE marking.
  • Experience in at least one of the sectors we serve: medical, security, or industrial/NDT.
  • Strong communication skills—you can translate regulations into practical action.
  • Hands-on and resourceful—you don’t wait to be told what to do and proactively encourages the team towards common goals.

Nice-to-haves:

  • Experience with digital imaging or X-ray systems.
  • Certifications like RAC, ASQ CQA, or CMQ/OE.
  • Familiarity with EU MDR or international regulatory pathways.

Why Join Us?

  • High-impact role: You’ll shape how we build and deliver safe, reliable, and compliant systems.
  • Cutting-edge tech: Work at the intersection of hardware, software, and real-world outcomes.
  • Startup energy, real-world stakes: We're agile but deeply committed to doing things right.
  • Great team: Collaborative, smart, mission-driven folks who care about the work and each other.

Sound like a fit? Let’s talk.

You’ll help us stay compliant while moving fast—and build quality into everything we ship

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