Director of Quality Engineering

Pro Edge Dental Products Inc•Centennial, CO

22d•$140,000 - $170,000•Hybrid

About The Position

ProEdge Dental Water Labs is seeking a Director of Quality Engineering to shift quality from compliance inspection and documentation to defect prevention and process control within 12 months, driving operational consistency, fewer defects, stronger audit outcomes, and developing a small team. This position focuses primarily in quality engineering and process improvement (primary focus), serves as the effectiveness owner of the Quality Management System (QMS), and provides regulatory oversight aligned to FDA and ISO standards. This is not a compliance-first role, but a quality-first role. Reporting to the President of the organization, you’ll have significant responsibility to deliver measurable improvements in process reliability, powers our product pipeline, and transforms quality into a competitive advantage.

Requirements

Disciplined with root cause to improve systems rather than shifting problems
Strong record of continuous improvement leading to better business outcomes
Seeks out others' ideas and critiques, while not needing consensus
Works hard, gets hands dirty, and moves things forward even with setbacks
Unsatisfied with checking regulatory boxes rather than pursuing excellence and prevention
Team-first and self-improving
Tells the truth even when it may put them in a vulnerable position
Recognizes the work is for a customer and patient's benefit, and puts them in the heart of every process
Makes consistently wise decisions
Can clearly communicate their thinking, distilling, and learning

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.
Own and elevate the executive management review process, delivering proactive quality and regulatory insights that shape product roadmap decisions, risk mitigation, and cross-functional priorities.
Ensure quality is fully integrated, trusted, and supported as a strategic partner across organization culture and decision-making to customer/patient benefit.