Senior Director, Quality

Company Overview

VERO Biotech is an Atlanta-based medical technology company that develops and commercializes portable, tankless inhaled nitric oxide (NO) delivery systems for cardiopulmonary conditions. We are seeking a visionary leader to head our Quality Engineering department, overseeing both the Design Quality and Sustaining Quality functions. This role is pivotal in ensuring that our innovation pipeline is robust and our commercialized products maintain the highest standards of safety and performance

Position Summary

Reporting directly to the Vice President of Quality, the (Senior) Director of Quality Engineering will lead a high-performing team of engineers dedicated to the full product lifecycle. You will serve as the primary quality stakeholder for New Product Development (NPD) and post-market product maintenance.

On the Design Quality side, you will be the champion of Risk Management and Design Controls. Your expertise will guide the team through complex Verification & Validation (V&V) strategies, Usability Engineering (Human Factors), and Software Quality Assurance (IEC 62304), ensuring that every product reaching Design Transfer is primed for clinical and commercial success.

On the Sustaining Quality side, you will bridge the gap between R&D and Operations. Your focus will be on maintaining the integrity of the Design History File (DHF) and Device Master Record (DMR) while overseeing Change Control, Process Validation (IQ/OQ/PQ), and the implementation of Statistical Process Control (SPC). You will lead the technical response to NCMRs and CAPAs, ensuring rigorous impact assessments and data-driven continuous improvement in a manufacturing environment.

Key Responsibilities

• Strategic Leadership: Develop and execute a comprehensive Quality Engineering roadmap that aligns with corporate growth and regulatory compliance.

• Risk Management & Compliance: Maintain a world-class Risk Management program (ISO 14971), ensuring hazards are identified and mitigated throughout the product life.

• Operational Excellence: Lead the quality oversight of manufacturing processes, utilizing Six Sigma and Lean methodologies to drive yields and reduce non-conformances.

• Cross-Functional Collaboration: Act as the key quality liaison for R&D, Operations, Regulatory Affairs, and Clinical teams to ensure seamless product transitions.

• Audit Readiness: Serve as a subject matter expert during FDA inspections and Notified Body audits (ISO 13485/MDR).

• Talent Development: Mentor and grow a team of quality professionals, fostering a culture of "Quality by Design" rather than "Quality by Inspection."