Job Description
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 a 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 era.
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
8uyj2Q3viS
#J-18808-Ljbffr