Senior Manager Quality Systems

Lead the development, deployment, and continuous improvement of a harmonized global QMS aligned with internal policies, ISO 13485, FDA (21 CFR 820/QMSR), EU MDR, and other applicable regulations.

Establish standard work, governance, and KPIs to ensure consistent audit execution and audit readiness across all sites.

Act as global process owner for key quality system elements, including internal audits, external audits, CAPA effectiveness, and risk management.

Develop and execute a global, internal audit program across all manufacturing sites and functions.

Ensure readiness for regulatory, customer, and notified body audits; provide leadership during inspections (front room/back room support).

Identify systemic gaps and drive timely, effective remediation and CAPA closure.

Develop and implement ...