ProEdge Dental Water Labs · 2 hours ago
Quality Engineering Manager
Centennial,CO,US
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $140K/yrProEdge Dental Water Labs is a dynamic company focused on transforming compliance in the dental practice into a culture of shared purpose. They are seeking a Quality Engineering Manager to shift quality from compliance inspection to defect prevention and process control, driving operational consistency and measurable improvements in process reliability.
Health CareMedical DeviceWholesale
Responsibilities
Lead the validation and successful launch of new Class I medical devices, ensuring 100% compliance with FDA general controls and ISO 13485 standards
Implement 3-5 targeted process optimizations (e.g., Lean/Six Sigma tools) that reduce process variability and improve first-pass yield by 15-25% by 18 months
Drive process-related non-conformances and defects to near 0 through targeted engineering improvements and root cause analyses by 18 months
Support regulatory compliance for new products and ongoing operations, achieving zero major findings in internal/external audits by 18 months
Quality is fully integrated into decision-making across operations, engineering, and supply chain to customer/patient benefit
Qualification
Required
Lead the validation and successful launch of new Class I medical devices, ensuring 100% compliance with FDA general controls and ISO 13485 standards
Implement 3-5 targeted process optimizations (e.g., Lean/Six Sigma tools) that reduce process variability and improve first-pass yield by 15-25% by 18 months
Drive process-related non-conformances and defects to near 0 through targeted engineering improvements and root cause analyses by 18 months
Support regulatory compliance for new products and ongoing operations, achieving zero major findings in internal/external audits by 18 months
Quality is fully integrated into decision-making across operations, engineering, and supply chain to customer/patient benefit
Problem-solver – Candidate is disciplined with root cause to improve systems rather than shifting problems
Results – Candidate has a strong record of continuous improvement leading to better business outcomes
Collaborative – Candidate seeks out others' ideas and critiques, while not needing consensus
Entrepreneurial Grit – Candidate works hard, gets hands dirty, and moves things forward even with setbacks
High standards – Candidate is unsatisfied with checking regulatory boxes rather than pursuing excellence and prevention
Humble – Candidate is team-first and self-improving
Transparent – Candidate tells the truth even when it may put them in a vulnerable position
Customer-focus – Candidate recognizes the work is for a customer and patient's benefit, and puts them in the heart of every process
Discerning – Candidate makes consistently wise decisions
Smart - Candidate can clearly communicate their thinking, distilling, and learning
Benefits
Company paid medical/vision/dental premiums for Employees with flex options
4% Pre-Tax Employer Match 401k
Accrued Paid time off (PTO) earning up to 4 weeks annually
9 Paid holidays
Company
ProEdge Dental Water Labs
ProEdge Dental Water Labs provides waterline maintenance and testing products and consultation services to dental professionals.
Founded in 2003
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Caroline Asimakopoulos
Chief Financial Officer
Recent News
Google Patent
2025-02-17
Company data provided by crunchbase