Job Description
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
o 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
o 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
* Completion of Capstone, Co-Op, or project in the medical device field
* Experience with medical devices and Risk Analysis and Design Transfer
* Experience with compliance to applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
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.
#J-18808-Ljbffr