Quality Systems Engineer II - CAPA
Core
Support the Corrective and Preventative Action (CAPA) process, including investigations and nonconforming events, to ensure compliance with internal requirements and external regulations.
Role type
Quality Systems Engineer II
Builds
Robust, compliant CAPA records and sustainable corrective/preventive actions
Domain
Medical device / Pharmaceutical quality systems
Deliverable
dashboards & analysis
Required skills
Root cause analysis, CAPA lifecycle management, risk assessment, project management, systematic problem-solving, regulatory compliance (FDA, ISO 13485), data tracking
Preferred skills
Mentorship, cross-functional collaboration, continuous improvement methodologies
Responsibilities
Mentor cross-functional CAPA teams on root cause analysis and corrective action plans; Provide guidance on nonconformance investigations and material/product containment; Assess CAPA activities and documentation for regulatory compliance; Apply systematic problem-solving to resolve quality issues; Partner with stakeholders to drive standardization of best practices; Track actionable CAPA metrics and trends; Support site and global CAPA initiatives; Drive continuous improvement for a preventive quality culture