The role involves supporting the development and maintenance of Quality Management System processes to ensure full compliance with FDA and ISO regulations
Job Summary
The role involves supporting the development and maintenance of Quality Management System processes to ensure full compliance with FDA and ISO regulations.
Candidates will serve as a Regional Site CAPA Lead, providing hands-on support for investigations, root cause analysis, and corrective action plans in North America.
The position requires leading monthly Nonconformance Coach meetings to promote consistency and effective issue resolution across the regional team.
Matching Summary
The role involves supporting the development and maintenance of Quality Management System processes to ensure full compliance with FDA and ISO regulations.
Skills & Requirements
Must-have
FDA 21 CFR 820 compliance
ISO 13485 quality standards
CAPA investigation management
Root cause analysis expertise
Nonconformance record maintenance
Nice-to-have
Mentorship of regional teams
Continuous improvement initiatives
Cross-functional collaboration skills
Knowledge sharing facilitation
Key Requirements
Degree level qualification or equivalent experience