Product Complaints Engineer - Team Lead

DEKA R&D has an immediate opening for a Product Complaints Engineer - Team Lead 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 :

• Will lead a small team of Product Complaints Engineers focused on one or more of DEKA’s innovative, life-changing medical devices.
• Responsible for reviewing complaints related to potential device-related 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.
• Track complaint processes to identify areas of improvement.
• Author procedures and work instructions.
• Establish and maintain a product training program.
• Contribute independently while also collaborating with other team members and departments.
• Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
• Perform other related duties as assigned under management supervision.

Skills needed to be successful :

About DEKA :