Company located south of Boston is seeking LOCAL candidates for their Quality Engineering position. This is a long term contract position within the MEDICAL DEVICE industry with a strong possibility of going permanent. This position has lots of growth opportunity! It is required that you have that you have 4-5 years in medical device quality assurance as well as a good understanding of FDA Quality System regulations, EU Active Implantable and Medical Device Directives. As a Quality Engineer you will plan develop and execute verification and validating testing on products that are still under development and be responsible for providing design control quality assurance functions. It is also required that you have significant experience with FDA and GMP practices as well as CAPA and non-conforming processes and ISO 13485. It is required that candidates have their B.S. Degree in Engineering or related field and it is desirable that you have your ASQC Certification, Six Sigma knowledge as well as an understanding of IEEE software quality standards. Candidates with a background or knowledge in the following disciplines will be most highly desired; experience with Class II and Class III medical devices, QSR, ISO 14971, FMEA, familiarity with GD&T, equipment and process validation experience (IQ/OQ/PQ), DFSS, DFMS
Location: South of Boston
Compensation: Negotiable
Principals only. Recruiters, please don't contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.
rhodeisland
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