Product Complaints Engineer

Job description

DEKA R&D has an immediate opening for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant direct impact in the Quality Management System. How you will make an impact: - Responsible for reviewing complaints related to potential medical device issues. - Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge. - Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements. - Identify and make sound decisions regarding medical device reporting to regulatory agencies. - Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies. - Participate in audits and CAPA investigations as they relate to complaint handling. - Work with the forensic investigation team to align product investigations related to complaints. - Generate reports to identify areas of process improvement. - Develop product traini...