DEKA Research & Development, located in Manchester, NH, is seeking a Junior Quality Engineer to provide design quality support in a dynamic, fast-paced environment of medical device R&D and manufacturing.
How you will make an impact as a Junior Quality Engineer:
- Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
- Evaluate project and design compliance to applicable standards and regulations
- Use critical thinking and analysis to determine the best approach and provide guidance on QMS compliance to design team members
- Support development of complex electromechanical devices including software through quality system processes
- Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis
- Assist in the development, implementation and approval of Device Master Records and Device History Records
- Participate in investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
- Coordinate the efforts of individuals and teams performing investigations
- Ensure the accurate documentation and recording of information to be used in communication with partners and regulatory bodies
- Support system and process improvements using six sigma tools
- Support reliability and statistical analysis
- Support in internal and external audits
To be successful in this role as a Junior Quality Engineer, you will need the following skills:
- Bachelor’s degree in Biomedical, Mechanical, Electrical, or a related engineering 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
- 1+ years of experience in any suitable occupation related to quality control of medical devices preferred
- Completion of Capstone, Co-Op, or Internship project in the medical device field preferred
- Experience with medical devices and Risk Analysis and Design Transfer preferred
- Experience with compliance to applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 preferred
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.
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What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester.
DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality.
DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
