Overview

Junior Quality Engineer Jobs in Manchester, NH at DEKA Research & Development

Title: Junior Quality Engineer

Company: DEKA Research & Development

Location: Manchester, NH

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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