Director of Quality Programs – Integrated Supply Chain

About the role

The Director, Quality Programs‑Integrated Supply Chain (ISC) provides strategic leadership for enterprise and site‑level quality programs within FDA‑regulated medical‑device manufacturing environments. You will lead large‑scale, global, cross‑functional programs that strengthen the quality management system, improve compliance and drive operational excellence.

Key responsibilities

• Lead, mentor and manage a team of Program Managers and data analysts responsible for quality programs.
• Develop and implement strategic plans for quality programs, including AI initiatives, aligned with regulatory requirements.
• Oversee planning, execution and completion of quality compliance projects, ensuring timelines, budgets and objectives are met.
• Monitor adherence to industry standards and internal policies, adjusting programs to maintain compliance.
• Collaborate with Operations, Engineering, Business and Supply Chain to drive cross‑functional quality outcomes.

Required profile

• Minimum 10+ years’ experience in FDA‑regulated medical‑device manufacturing or supply‑chain environments.
• Proven track record in large‑scale, global quality program/project management and team leadership in a matrix organization.
• Strong understanding of medical‑device regulations and standards (ISO 13485, ISO 14971, 21 CFR, MDD/EU MDR, GMP, GDP).
• Bachelor’s degree in Quality, Engineering or related scientific discipline (advanced degree or certifications such as Six Sigma, PMP preferred).

Required skills

• Artificial Intelligence (AI) concepts applied to quality programs.
• Data analytics and quality KPI analysis.
• Experience with regulatory standards implementation and compliance.