Senior Director, Quality

VERO BIOTECH INC•Atlanta, GA

26d•Onsite

About The Position

VERO Biotech is an Atlanta-based medical technology company that develops and commercializes portable, tankless inhaled nitric oxide delivery systems for cardiopulmonary conditions. The Senior Director, Quality leads the Quality Engineering department, including Design Quality and Sustaining Quality, and oversees quality throughout the full product lifecycle. Reporting to the Vice President of Quality, this role is the primary quality stakeholder for New Product Development and post-market product maintenance. The Design Quality function champions Risk Management and Design Controls and guides Verification and Validation strategies, Usability Engineering (Human Factors), and Software Quality Assurance under IEC 62304, ensuring products are prepared for clinical and commercial success at Design Transfer. The Sustaining Quality function connects R&D and Operations, maintaining the Design History File and Device Master Record while overseeing Change Control, Process Validation (IQ/OQ/PQ), and Statistical Process Control. The role also leads technical responses to NCMRs and CAPAs, including impact assessments and data-driven continuous improvement in manufacturing. The position leads, mentors, and develops Quality Engineering personnel and may manage managers or cross-functional project leaders, depending on level and organizational structure. The Senior Director is expected to define global quality strategies, manage significant departmental budgets, navigate complex regulatory submissions for Class II or Class III devices, and lead high-stakes interactions with global regulatory bodies. The work is in a standard office environment, with possible periodic interaction with manufacturing, laboratory, or controlled production environments.

Requirements

Bachelor’s degree in engineering or a related Life Science field.
At least 15 years of medical device industry experience for the Senior Director level.
At least 8 years managing managers or leading large, multi-site functional teams for the Senior Director level.
Proven track record managing Design Controls and Sustaining Engineering projects.
Deep understanding of FDA 21 CFR 820 and ISO 13485.
Proficiency with statistical tools.
Direct experience with Process Validation and NCMR management.
Experience defining global quality strategies, managing significant departmental budgets, navigating complex regulatory submissions for Class II or Class III devices, and leading high-stakes interactions with global regulatory bodies.
Strong technical judgment, analytical thinking, and data-driven decision-making.
Ability to influence cross-functional stakeholders and drive quality-focused outcomes.
Ability to manage multiple tasks and projects, organize substantial information, and work independently.
Ability to work collaboratively and interact with individuals at all organizational levels and across multiple sites.

Nice To Haves

An advanced degree such as a Master’s, PhD, or MBA is strongly preferred.

Responsibilities

Develop and execute a Quality Engineering roadmap aligned with corporate growth and regulatory compliance.
Maintain the Risk Management program in accordance with ISO 14971 and ensure product hazards are identified and mitigated throughout the product life.
Lead quality oversight of manufacturing processes and use Six Sigma and Lean methodologies to improve yields and reduce non-conformances.
Serve as the quality liaison for R&D, Operations, Regulatory Affairs, and Clinical teams to support seamless product transitions.
Act as a subject matter expert during FDA inspections and Notified Body audits.
Mentor and develop Quality Engineering personnel and foster a culture of Quality by Design.
Oversee Design Quality activities, including Design Controls, Verification and Validation, Usability Engineering, and Software Quality Assurance.
Oversee Sustaining Quality activities, including DHF and DMR integrity, Change Control, Process Validation, and SPC.
Lead technical responses to NCMRs and CAPAs, ensuring impact assessments and data-driven continuous improvement.
For the Senior Director level, define global quality strategies, manage significant departmental budgets, and lead high-stakes interactions with global regulatory bodies.