DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment.  The position reports to the Quality Manager.  We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment. How you will make an impact: + Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485 + Participate in and lead Risk Management activities in accordance with ISO 14971 + The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation. + Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills. + Coordinate the efforts of individuals and teams performing investigations. + Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA. + Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations. + Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies. + Prepare detailed work plans and procedures such as Validation Plans. + Evaluate and approve proposed design or manufacturing process change. + Drive system and process improvements. + Provide reliability and statistical analysis. + Participate in internal and external audits. How you will be successful in this role: + Bachelor’s degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree. + Minimum 2-5 yrs. of recent professional experience (medical device experience is preferred) as QE in a regulated manufacturing environment.  + Must be detail oriented and have strong communication both written and verbal. + Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred. + Ability to: + Multitask and carry tasks through to completion + Manage multiple sources of data and develop reports 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