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." 

Qualifications

Director Level: Bachelor’s degree in engineering or a related Life Science field and at least 10 years of progressive experience in the medical device industry, including at least 5 years in a leadership or people-management role. Candidates should have a proven track record managing Design Controls and Sustaining Engineering projects, a deep understanding of FDA 21 CFR 820 and ISO 13485, proficiency with statistical tools, and direct experience with Process Validation and NCMR management.

Senior Director Level: In addition to the Director-level requirements, the Senior Director role requires at least 15 years of medical device experience, including at least 8 years managing managers or leading large, multi-site functional teams. An advanced degree such as a Master’s, PhD, or MBA is strongly preferred. Candidates should have defined global quality strategies, managed significant departmental budgets, navigated complex regulatory submissions for Class II or Class III devices, demonstrated advanced analytical skills, and successfully led high-stakes interactions with global regulatory bodies.

Supervisory Responsibilities 

This position leads, mentors, and develops Quality Engineering personnel and may manage managers or cross-functional project leaders, depending on level and organizational structure.

Competencies 

• Comfortable in a fast-paced environment handling multiple tasks and projects.
• Able to organize and manage large amounts of files, tasks, schedules, and information.
• Self-directed and able to work without supervision.
• Energetic and eager to tackle new projects and ideas.
• Must be a team player.
• Comfortable interacting with individuals at all levels of the organization and across multiple sites.
• Strong technical judgment, analytical thinking, and data-driven decision-making.
• Demonstrated ability to influence cross-functional stakeholders and drive quality-focused outcomes.

Physical Demands and Work Environment

• Standard office environment.
• May require periodic interaction with manufacturing, laboratory, or controlled production environments, as applicable.