DEKA R&D has an immediate opening for a Complaint Handling 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 that involve a potential quality problem with a medical device.  + 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. + Edit procedures and work instructions. + Develop product training aids. + Generate reports to track and trend complaints across product lines. + Work with failure analysis team to inform product investigations related to complaints. + 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. + 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: + 4-year engineering degree, preferably in biomedical engineering; OR 2-year degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis. + Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. + Experience with SalesForce is preferred. + Good problem-solving and proficient computer skills are required. + Solid written/verbal communication and organizational skills, as well as attention to detail. + Sound technical writing skills. + Excellent time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures. + Ability to work well independently and on cross-functional teams in a fast-paced, changing environment. + Motivated self-starter with a strong desire to see individual tasks through to completion, and to help as needed to achieve team goals. 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.   Powered by JazzHR