Senior Quality Systems Engineer
Core
Own and execute CAPA activities within field action and quality systems processes to drive continuous improvement and close identified gaps in regulated environments.
Role type
Senior Quality Systems Engineer
Builds
Quality system performance and compliance within regulated environments
Domain
Regulated industry (Medical Device implied by context)
Deliverable
dashboards & analysis
Required skills
CAPA management, root cause analysis, systematic problem-solving, cross-functional collaboration, project leadership, data tracking and trending
Preferred skills
Medical device industry experience, field action/PIR process support, continuous improvement drive, global/multi-site environment experience
Technologies
Microsoft Office Suite
Responsibilities
Support site CAPA and NCEP activities as a SME, track and trend CAPA/NCEP information for review boards, champion quality and compliance throughout processes, lead continuous improvement projects, identify areas for improvement in NCEP/CAPA, apply systematic problem-solving methodologies, contribute to global Communities of Practice
Seniority
Senior, hands-on IC