A Nonconformance Evaluation Specialist job in Bloomington, IN is available courtesy of Adecco Engineering and Technology. You will be involved with a long-term remediation project where you will be tasked with investigating nonconformance issues with a process focus. It is essential that you have worked in a medical device environment during remediation efforts previously, and any direct contact with the FDA is preferable. There is a competitive hourly rate as well as expense package in place.
Nonconformance Evaluation Specialist job responsibilities include:
• Assessing and evaluating the affect manufacturing issues/nonconformances have on products and the potential associated risk and detection capability in order to determine need for escalation to field action and/or CAPA
• Working with and mentoring product, development, and quality engineers in the execution of nonconformance evaluations/investigations
• Risk management per ISO 14971, complaint investigation, and NC and their linkage with process and product nonconformance evaluations/ investigations
• Four year Bachelor's degree
• A minimum of five years' in a similar role is required
• Experience with requirements of 21CFR820.70 and 21CFR820.90
• Experience in the evaluation and disposition of nonconforming product and identification of corrections
• Experience in investigating/evaluating various types of process events that occur within a manufacturing environment (such as equipment out of tolerance conditions and environmental excursions) and determine the potential impact the events have on the product/material conformance to specifications
If you are interested in this Nonconformance Evaluation Specialist job in Bloomington, IN then please click APPLY NOW. For other opportunities available at Adecco Engineering and Technology go to www.adeccousa.com. If you have questions about the position please contact Jim Cullen at 317-558-1036 or firstname.lastname@example.org.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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