Quality Engineering Manager

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.

• 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

• 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

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

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.

• $110,000 – $140,000 base salary + annual bonus
• Company-paid medical, dental, and vision