Quality Management System/CAPA Specialist
Core
Facilitate the CAPA process and support Audit Readiness activities to ensure an efficient and compliant Quality Management System (QMS) in the Medical Device industry.
Role type
Senior IC Quality Management System/CAPA Specialist
Builds
QMS processes, SOPs, work instructions, and quality manuals
Domain
Medical Device / Regulatory Compliance
Required skills
CAPA management, root cause analysis, risk assessment, data analysis, regulatory knowledge (QMSR, ISO 13485, ISO 9001, EU MDR), technical writing, stakeholder management
Preferred skills
ASQ-CQE certification, experience with FDA regulated environments
Technologies
QMSR, ISO 13485, ISO 9001, EU MDR
Responsibilities
Monitor process performance and prepare detailed reports on QMS metrics; Conduct risk assessments and develop mitigation strategies; Lead cross-functional problem-solving sessions using structured methodologies; Prepare for and participate in external regulatory audits; Contribute to the development and revision of QMS processes and documentation.
Seniority
Senior, hands-on IC