Product Complaints Specialist

DEKA R&D has an immediate opening for a Product Complaints Specialist to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a role with direct impact to the Quality Management System.

How you will make an impact :

• Responsible for reviewing and entering complaint information related to potential medical device issues.
• Generate requests for additional information to complete complaint evaluations.
• Perform product complaint evaluations independently while also collaborating with other team members.
• 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.
• Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.
• Influence the creation of new procedures and work instructions.
• 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 :

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.