Paula Kauffman

Managed the Quality Assurance, Manufacturing, and Logistics departments in accordance with ISO 13485. Responsible for adherence to the Quality System which included initiation, revision, implementation, and control of quality documentation. Prepared and performed internal audits, maintained supplier files, and monitored Corrective Actions. Scheduled, issued and executed manufacturing orders and applicable documentation requirements to meet clinical demands. Performed all purchasing functions to procure manu

Reviewed product related complaints, ensured timely investigation, submission of MDR/Vigilance Reports, and closure in accordance with FDA Quality System Regulations and ISO 13485. Responsible for trending complaints and reported information to Complaint Handling teams. Performed training on complaints / MDRs to employees.

Reviewed and processed product related complaints, ensured timely investigation, submission of MDR/Vigilance Reports, and closure in accordance with FDA Quality System Regulations. Participant in internal and FDA audits and product recall activities.

Responsible for reviewing and processing product complaints, perform internal audits and submission of corrective actions. Responsible for the manangement of Document Control.

Managed the Quality Assurance and Manufacturing departments and participate in FDA audits. Responsible for adherence to the Qualty System as well as initiation, revision and control of quality system documentation. Performed internal and supplier audits as well as maintain supplier files and monitor corrective actions. Planned and managed manufacturing schedules to meet customer demand. Managed Inspection/Testing, Manufacturing, Quality Document Control, Purchasing, Planning, Shipping, Receiving, and Wareho