Experienced Quality Assurance professional with a demonstrated history of supporting quality systems to advance the development and manufacture of active implantable medical devices including reporting adverse events to US and international agencies, data and document review and approval, as well as conducting internal audits and participating in external audits. A proven track record in complaint handling activities that reduced the complaint log by 90% within 90 days actively coordinates investigation actions for complaints, NCR's and CAPA's activities including effectiveness evaluation and closure, provide trend analysis on complaint, CAPA and NCR metrics.

Highlights:

• Audit
• Complaints
• Generate Reports
• Internal audit
• Regulatory Reporting
• Trend Analysis
• ISO
• Quality
• Quality Assurance
• Training