Supports global oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system, ensuring compliance to FDA 21 CFR Part 820, ISO 13485:2016, and other applicable global Quality System Regulations
Job Summary
Supports global oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system, ensuring compliance to FDA 21 CFR Part 820, ISO 13485:2016, and other applicable global Quality System Regulations.
Assists in maintaining the global NC/CAPA process, including monitoring process performance, implementing continuous process improvement, and providing guidance to NC/CAPA Owners and Leads.
Works cross-functionally with internal teams and external partners globally, supports internal and external audits, and hosts/participates in Corporate NC/CAPA Escalation & Board meetings.
Matching Summary
Supports global oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system, ensuring compliance to FDA 21 CFR Part 820, ISO 13485:2016, and other applicable global Quality System Regulations.
Skills & Requirements
Must-have
Global NC/CAPA system oversight
FDA 21 CFR Part 820 compliance
ISO 13485:2016 compliance
Medical Device Single Audit Program
TrackWise module experience
Remote work communication skills
Nice-to-have
Methodical problem-solving
Lean / Six Sigma / KT methodology
Cross-functional collaboration
Continuous process improvement culture
Proactive communication
Key Requirements
Minimum 5 years supporting global NC/CAPA
Bachelor’s Degree in Science, Engineering, or related
Intermediate to Expert TrackWise skill level
Knowledge of ISO 13485:2016, 21 CFR Part 820, MDSAP