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
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 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 for communication with partners and regulatory bodies
* Support system and process improvements using Six Sigma tools
* Support reliability and statistical analysis
* Assist in internal and external audits
Minimum Requirements:
* Bachelor’s degree in Biomedical, Mechanical, Electrical, or related engineering discipline
* Ability to work as part of a multidisciplinary team
* Excellent verbal and written communication skills, with attention to detail
* Ability to understand and provide guidance on quality system procedures
* 1+ years of experience in quality control of medical devices or related fields
* Completion of Capstone, Co-Op, or project in the medical device field
* Experience with medical devices, Risk Analysis, and Design Transfer
* Experience with compliance to standards like 21 CFR 820 and ISO 13485:2016
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