DEKA Research & Development

Junior Quality Engineer

DEKA Research & Development, Manchester

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:

n
Aptitude for Learning Technical Information: Ability to comprehend and apply technical concepts effectively. Strong engineering foundation and technical skills.
n
n
Project Coordination/Management: Skilled in planning, executing, and managing projects with varying timelines.
n
n
Problem Solving: Embrace challenges and find creative solutions.
n
n
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.
n
n
Attention to Detail: Display exceptional accuracy and precision in all tasks.
n
n
Effective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitude
n
n
Self-Motivated: Able to self-prioritize and work independently.
n
n
Technical Writing: Proficient in conveying complex technical information clearly and concisely to as variety of audiences.
n
n
Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio.
n

As a Jr. Quality Engineer, you will contribute in the following areas:

n
Ensure an overall level of product quality in line with DEKA’s standards
n
n
Support and participate in development of complex electromechanical devices
n
n
Assist in the development, implementation and approval of Device Master Records and Device History Records
n
n
Attain a comprehensive understanding of device design and core technologies, leveraging this knowledge to drive investigations and improvements in product design and process.
n
n
Participate in investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
n
n
Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis
n
n
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
n
n
Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements.
n

To be successful in this role as a Junior Quality Engineer, you will need the following skills:

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

Nice skills to have:

n
Knowledge of FDA’s Quality System Regulation
n
n
Knowledge of ISO 13485 and related standards
n
n
Experience with Corrective and Preventive Action (CAPA)
n
n
1+ years’ experience in quality systems management, CAPA, quality assurance or a similar regulated environment
n

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.