Senior Quality Systems Specialist
Core
Ensure effectiveness of quality management system by driving compliance, leading problem-solving efforts, and partnering with cross-functional teams to resolve quality issues.
Role type
Senior Quality Systems Specialist
Builds
Quality management system compliance and continuous improvement
Domain
Medical device manufacturing
Deliverable
dashboards & analysis
Required skills
CAPA process management, root cause analysis, audit support, KPI monitoring, training program development, cross-functional collaboration, problem-solving methodologies
Preferred skills
FDA/regulatory agency interaction, international medical device regulations, compliance-risk environment experience, multi-site quality initiatives
Technologies
eCAPA system, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Own and oversee Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes; Review and approve NCs and CAPAs for completeness and effectiveness; Partner with teams to facilitate investigations and corrective action implementation; Coach teams on problem-solving methodologies; Lead accountability meetings and root cause analysis workshops; Monitor and report NC/CAPA KPIs; Develop and deliver training programs; Support internal, corporate, customer, and third-party audits.
Seniority
Senior, hands-on IC
