Product Complaints Engineer

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 training aids.
• Contribute independently while also collaborating with other team members and departments needing product complaint information.
• Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
• Serve as a subject matter expert on complaint handling.
• Perform other related duties as assigned under management supervision.

Skills needed to be successful :

About DEKA :