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Job Title: Quality Support Operator
Location: Elkhart, IN 46515
Duration: Direct Hire
Schedule: Shift 1; M-F (8:00 AM - 5:00 PM)
Description:
•The Quality Support Operator 1 will assist in the maintenance and support of the Quality Management System at an in-vitro diagnostic manufacturing site.
•This position is a temporary, short term, individual contributor role and will interact with multiple functions within the site.
•Manage Quality records.
•Document, review, and file quality records.
•Manage consolidation and/or relocation or records within controlled archive locations.
•Assist Quality Group in support of related processes and documentation.
•Strong value orientation with the ability to lead teams and positively influence outcomes.
•Ability to effectively communicate with internal and external customers.
•Ability to demonstrate lean leadership skills.
•Attention to detail and neatness in generating written records.
Required Knowledge/Skills, Education, Experience
•High School Diploma.
Preferred Knowledge/Skills, Education, Experience:
•21 CFR 820 regulations and ISO 13485:2016 standard requirements.
•Regulated Industry Experience.
