Junior Quality Engineer

Overview

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.

• 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.

• 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 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

• 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

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.