What are the responsibilities and job description for the Junior Quality Engineer - medical devices position at InnoTech Staffing?
Job Description
Job Description
InnoTECH Staffing is looking to hire a Junior Quality Engineer for a product development company in Southern New Hampshire.
This is onsite 5 days a week. No sponsorship at this time.
We are 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
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