Junior Quality Engineer

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
  • 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
• 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.