Senior Quality Engineer

Senior / Principal QARA Engineer

Maclivaro Limited | Colorado, United States (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 Senior / Principal QARA Engineer to elevate quality into a true competitive advantage. This role is primarily focused on quality engineering, process control, and defect prevention, with regulatory responsibilities as a supporting function—not the center of gravity.

You’ll work closely with leadership and cross-functional teams to drive meaningful improvements, own critical quality systems, and help ensure compliance with FDA and ISO standards in a pragmatic, business-aware way.

This role is designed for someone who thrives in ambiguity, moves projects forward, and brings both raw process intelligence and customer awareness to everything they do.

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
• Proactively embed quality into operations, engineering, and supply chain decisions
• Independently drive cross-functional initiatives from problem identification through execution

What You’ll Bring

• Deep strength in root-cause problem solving, process optimization, and systems thinking
• Proven ability to drive projects forward in fast-paced, resource-constrained environments
• Strong judgment in balancing quality priorities with regulatory requirements
• Working knowledge of FDA and ISO 13485, with the ability to build regulatory capability through learning, courses, and external resources when needed
• Experience in continuous improvement methodologies (Lean, Six Sigma, or similar)
• High ownership mindset with a bias toward action

Who You Are

• Entrepreneurial and resourceful—you figure things out and make progress
• Discerning and pragmatic—you know where to go deep and where to move fast
• Customer- and patient-focused in every decision
• Humble, transparent, and highly collaborative
• Clear, thoughtful, and decisive communicator
• Hands-on and comfortable being close to the process

Work Style

This is primarily an on-site 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

• $110,000 – $140,000 base salary annual bonus
• Company-paid medical, dental, and vision
• 401(k) with 4% employer match
• Up to 4 weeks PTO
• 9 paid holidays