Junior Quality Engineer

• 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.

• 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, implementationand 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.

• BS or MS degree in Biomedical, Mechanical, Electrical, ora related engineering/ Science discipline
• Ability to work as part of a multidisciplinary team
• Excellent verbal and written communication skills, as well asattention to detail
• Ability to understand and provide guidance on quality system procedures
• Project coordination/ management skills
• Technical Writing experience
• Excel, Word, Visio skills

• Knowledge of FDA's Quality System Regulation
• Knowledge of ISO 13485 and related standards
• Experiencewith 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.