DEKA R&D has an immediate opening for a Product Complaint Manager to work in a dynamic Medical Device Research and Development environment.  The position reports to the Program Manager. This is a high visibility role with a significant impact to regulatory compliance and customer satisfaction.

How you will make an impact:Manages a diverse team of Complaints Specialists, monitors the performance of the team, and provides guidance and individual coaching as neededConducts, maintains, and creates product complaint and Adverse Event intake training, job aids, refresher slide decks and reference documents to ensure the Complaints Specialists respond to and process technical product complaintsUnderstands complexity of complaints to interpret and ensure proper classification and completeness before closureEscalates reports of potentially serious product issues to senior managementMonitors the product complaint mailbox and performs daily review, evaluation, corrections on complaint records. Resolves day-to-day inaccuracies and issuesEnsures routine deliverables to customers are accurate and on-timeObtains all relevant information and creates complaint record within databaseProcesses cases in compliance with local procedures and regulationsActs as Subject Matter Expert and otherwise provides support during auditsUnderstands appropriate regulations; applies knowledge to ensure accurate and timely complaint handlingProvides backup coverage for day-to-day activitiesPerforms other related duties as assigned under management supervisionSkills needed to be successful:Preferred bachelor’s degree with 5+ years experience in post market surveillance/ complaint handling in a regulated environment; management and medical device experience preferred. Additional experience and training considered in lieu of degreeStrong communication skills and detail oriented both oral and written, as well as an ability to communicate complex issues to resolve issues and mitigate risksStrong organizational and prioritization skills, customer service orientedExperience working with all levels of management and an ability to influenceAbility to manage multiple projects in a very fast-paced environmentExcellent interpersonal skills; experience developing important relationships with key stakeholders, refined conflict management and negotiation skillsExcellent analytical skills and proficiency in Office suite programsAbility to apply product complaint (and adverse event) knowledge to make sound judgment calls and drives continuous improvementsExperience with TrackWise preferred

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 and 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.