Head of Quality Engineering, Medical Devices

Vero Biotech, Inc.; Atlanta (GA); On-site; USD 170,000 - 230,000; Full time

Job summary

VERO Biotech, Inc. in Atlanta, GA seeks a (Senior) Director of Quality Engineering to lead the Design and Sustaining Quality functions across the full product lifecycle, ensuring safety and performance.

Reporting to the Vice President of Quality, you will drive Design Controls, V&V, DHF/DMR integrity, CAPA/NCMR response, and cross-functional collaboration with R&D, Regulatory Affairs, and Operations to bring robust, compliant products to market.

Qualifications

• Bachelor’s degree in engineering or related Life Science field with 10+ years in medical device, including 5+ years in leadership.
• Experience with FDA 21 CFR 820 and ISO 13485; proficiency with statistical tools; experience with Process Validation and NCMR management.

Responsibilities

• Strategic Leadership: Develop and execute a Quality Engineering roadmap aligned with growth and regulatory requirements.
• Risk Management & Compliance: Maintain ISO 14971 program ensuring hazards are identified and mitigated.
• Operational Excellence: Lead quality oversight of manufacturing processes using Six Sigma/Lean to improve yields.
• Cross-Functional Collaboration: Serve as quality liaison for R&D, Operations, Regulatory, and Clinical teams.
• Audit Readiness: Act as SME during FDA inspections and Notified Body audits (ISO 13485/MDR).
• Talent Development: Mentor and grow a team of quality professionals with a Quality by Design approach.

Skills

Leadership

Regulatory understanding

Quality mindset

Cross-functional collaboration

Education

Bachelor’s degree in engineering or related Life Science field

Advanced degree (MS/PhD/MBA) preferred

Tools

Statistical tools

Process Validation

NCMR management

Job description

VERO Biotech, Inc. in Atlanta, GA seeks a (Senior) Director of Quality Engineering to lead the Design and Sustaining Quality functions across the full product lifecycle, ensuring safety and performance.

Reporting to the Vice President of Quality, you will drive Design Controls, V&V, DHF/DMR integrity, CAPA/NCMR response, and cross-functional collaboration with R&D, Regulatory Affairs, and Operations to bring robust, compliant products to market.