Overview
Quality Engineer Jobs in Austin, Texas Metropolitan Area at TWELVE10
Title: Quality Engineer
Company: TWELVE10
Location: Austin, Texas Metropolitan Area
Quality Engineer – Fully Remote, GTM-Stage MedTech Startup
Hi reader. It is I, a human who wrote (some) of this. Do me a favor and at least read down to the “what’s in it for you section” before you continue doom scrolling on whatever social media you find least aggravating.
Twelve10 (my company, not my end client) has been retained by a private equity firm to build out the go-to-market (GTM) team for a groundbreaking medtech startup. This company is bringing software-enabled medical devices to market and is looking for a Quality Engineer to help shape its quality systems, compliance, and validation processes from the ground up.
What’s in it for you?
Fully Remote & Backed by Stability – Work from anywhere in the U.S. while being part of an early-stage startup that has the backing of a public company’s portfolio—meaning no layoffs, no funding uncertainty, just a clear path to growth.
Own Your Impact in a GTM-Stage Startup – This is the perfect time to step in, help build and refine quality processes, and play a pivotal role in getting products to market.
Diverse, Hands-On Role – You’ll work across quality systems, product validation, and vendor management, collaborating with R&D, regulatory, and manufacturing teams to ensure compliance and high standards.
Mission-Driven Work – Be part of a team tackling real healthcare challenges, improving patient outcomes with cutting-edge technology in wound & skin care.
What You’ll Be Doing
Implement and maintain the electronic Quality Management System (eQMS), manage NCRs and CAPAs, and ensure compliance with ISO 13485, ISO 14971, IEC 62304, and IEC 60601
Oversee product validation, including design verification & validation testing, and support FDA and regulatory interactions
Evaluate and monitor contract manufacturers and suppliers to ensure quality standards are met
Collaborate with cross-functional teams to align quality, risk management, and regulatory requirements with product development
Play a key role in ensuring software-enabled medical devices meet the highest quality standards
What You’ll Bring
Hi again reader- quick preface of the below, if you have 70% of the below, I’d still love to hear from you. You don’t need to tick all of the boxes, to be honest,
Experience in medical device quality systems, including ISO 13485, CAPA, and validation protocols
Familiarity with SaMD, IEC 62304, and software-related quality processes
A problem-solving mindset and ability to work in fast-moving, early-stage environments
Strong communication and collaboration skills to work across engineering, regulatory, and supplier teams
This role is ideal for someone who wants more than just a job—it’s a chance to shape quality processes in a growing startup while having the security of being backed by a public company.
If you made it this far, fire over your CV and I’ll genuinely try to get something on the books with you as this is an urgent hire.
I promise you I’m a delight to work with.
