We are seeking a Project Quality Engineer to provide Quality Leadership on a dynamic, fast paced medical device research and development team. How you will make an impact as a Project Quality Engineer:  + Work cooperatively with cross functional design team leads and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485:2016 + Use experience within product development or production of medical devices, to provide guidance and assistance in the development of new products. + Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations. + Participate in and lead Risk Management activities in accordance with ISO 14971:2019, such as; + Reviewing and approving Risk Management Plans + The development, implementation, and approval of Hazard Analyses, FMECAs, and other Risk Analysis documentation. + Support risk analysis during product anomaly reviews. + 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. + Assist in the development, review, and approval of Design History File documentation. + 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 Anomaly Management Plans. + Evaluate and approve proposed design changes. + Drive quality as a culture through system and process improvements. + Provide reliability and statistical analysis. + Participate in internal and external audits. + Interface with partners on quality topics. How you will be successful in this role: + Bachelor’s degree in an engineering discipline + A degree in a related STEM discipline (Physics, mathematics, etc.) may be considered with sufficient professional experience. + Minimum 5-8 yrs. of experience in Medical Device Quality Engineering + Experience in new product development strongly preferred. + Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 required.  + Experience supporting EU fielded product is a plus. + Experience developing and leading quality system procedures required. + Experience with direct responsibility for Risk Analysis and Design Transfer is preferred. + Experience supporting regulatory body submissions preferred.   + Experience participating in internal and external audits 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 & 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