Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Junior Quality Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality. Quality Engineering is a high-visibility role with a significant, direct impact on the success of the project. As a key contributor to our team, the following skills are required: + Aptitude for Learning Technical Information: Ability to comprehend and apply technical concepts effectively. Strong engineering foundation and technical skills. + Project Coordination/Management: Skilled in planning, executing, and managing projects with varying timelines. + Problem Solving: Embrace challenges and find creative solutions. + Collaboration: Effectively collaborate with various teams and departments, sharing ideas, taking initiative and proactively contribute to achieve common objectives. Work to maintain a positive attitude, fostering a supportive and productive work environment. + Attention to Detail: Display exceptional accuracy and precision in all tasks. + Effective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitude + Self-Motivated: Able to self-prioritize and work independently. + Technical Writing: Proficient in conveying complex technical information clearly and concisely to as variety of audiences. + Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio. As a Jr. Quality Engineer, you will contribute in the following areas: + Ensure an overall level of product quality in line with DEKA’s standards + Support and participate in development of complex electromechanical devices + Assist in the development, implementation and approval of Device Master Records and Device History Records + Attain a comprehensive understanding of device design and core technologies, leveraging this knowledge to drive investigations and improvements in product design and process. + Participate in investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills + Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis + Use critical thinking and analysis to determine the best approach and provide guidance on QMS, FDA Part 820, and ISO 13485 compliance to design team members + Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements. To be successful in this role as a Junior Quality Engineer, you will need the following skills: + BS or MS degree in Biomedical, Mechanical, Electrical, or a related engineering/ Science discipline + Ability to work as part of a multidisciplinary team + Excellent verbal and written communication skills, as well as attention to detail + Ability to understand and provide guidance on quality system procedures + Project coordination/ management skills + Technical Writing experience + Excel, Word, Visio skills Nice skills to have: + Knowledge of FDA’s Quality System Regulation + Knowledge of ISO 13485 and related standards + Experience with Corrective and Preventive Action (CAPA) + 1+ years’ experience in quality systems management, CAPA, quality assurance or a similar regulated environment 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