Quality Engineering Manager

Maclivaro Limited • Full-time • Colorado, United States, US • $110,000 - $140,000 / year • 3h ago

Quality Engineering Manager

Colorado | On-site

Industry: Medical Devices

We’re a fast-growing, mission-driven organization that is deeply culture-centric. We believe how we work matters just as much as what we build. Our team is made up of low-ego, high-agency builders who choose the harder right over the easier wrong—and who genuinely care about one another, our customers, and the patients we ultimately serve.

Quality here isn’t about box-checking. It’s about ownership, prevention, and pride in the work.

The Opportunity

We’re seeking a Quality Engineering Manager to help transform quality from inspection and documentation into process control, defect prevention, and competitive advantage. Reporting directly to the President, you’ll own quality engineering and process improvement, serve as the effectiveness owner of the QMS, and provide regulatory oversight aligned with FDA and ISO standards.

This is a quality-first role, designed for someone who wants to build systems that last and a culture that people believe in.

What Success Looks Like

Lead validation and launch of new Class I medical devices with full FDA and ISO 13485 compliance
Deliver 3–5 targeted process improvements driving 15–25% gains in first-pass yield
Reduce process-related defects and nonconformances to near zero
Achieve zero major findings across internal and external audits
Embed quality into everyday decisions across operations, engineering, and supply chain

What You’ll Bring

Strong root-cause problem-solving and systems thinking
Demonstrated success in continuous improvement
Collaborative, high-ownership leadership style
Entrepreneurial grit and a hands-on mindset
High standards that go beyond compliance

Who You Are

Culture-first and team-oriented
Humble, transparent, and growth-minded
Customer- and patient-focused in every decision
Thoughtful, clear, and decisive communicator

Work Style

This is primarily an on-site leadership role in Colorado, with hybrid flexibility. Being present—on the floor, in the process, and with the team—is essential to how we build trust, quality, and culture. Flexibility is real here, but so is the belief that the best work happens together.

Compensation & Benefits