Junior Quality Engineer - medical device

Job Description

InnoTECH Staffing is seeking a Junior Quality Engineer to provide design quality support in a dynamic, fast-paced environment of medical device R&D and manufacturing for a company in Southern, NH.

This is onsite 5 days a week. There is no sponsorship.

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

T

o 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

Full-time