Maclivaro Limited · 6 hours ago
Quality Engineering Manager
Colorado, United States
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $140K/yrMaclivaro Limited is a fast-growing, mission-driven organization focused on quality in the medical devices industry. The Quality Engineering Manager will lead the transformation of quality processes, ensuring compliance with FDA and ISO standards while driving process improvements and defect prevention.
Staffing & Recruiting
Hiring Manager
Olivia MacDonald
Responsibilities
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
Qualification
Required
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
Benefits
Company-paid medical, dental, and vision
401(k) with 4% employer match
Up to 4 weeks PTO
9 paid holidays
Company
Maclivaro Limited
Maclivaro is a family-run consultancy specialising in recruitment for medical devices, engineering, and the life science sector.
Founded in 2025
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase