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Product Complaint & Requirements Analyst

A-Line Staffing Solutions., Covington, GA, United States


A-Line Staffing is now hiring Product Complaint & Requirements Analyst in Covington, GA 30014. The Product Complaint & Requirements Analyst would be working for a Major Medical Device Manufacturer and has career growth potential. Product Complaint & Requirements Analyst Highlights: Schedule: Monday ??? Friday, 8:45 AM ??? 5:45 PM Pay Range: $33/hour Product Complaint & Requirements Analyst Responsibilities: Provides support to Project Teams and Quality Department Responsible for all product testing in the Complaint Laboratory Provides Quality Engineering technical support to assist in resolving quality issues, including complaint review and investigation Performs complaint investigations for all UCC products and applicable OEM manufactured products Creates and manages investigation files in the complaint system (Trackwise) Coordinates complaint investigation files and collaborates with manufacturing sites to ensure timely completion Sets up, safely operates, and maintains laboratory equipment and testing instruments Performs tests and experiments in accordance with GMP and GLP requirements Maintains working knowledge of company policies, ISO standards, and FDA requirements Maintains accurate data, performs analysis, and assists in drawing conclusions Ensures high attention to detail and accuracy in all tasks Works in a biohazard environment while complying with all safety procedures Ensures compliance with departmental and divisional procedures Interfaces with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups Presents findings to peers, engineering teams, and management as needed Provides timely notifications to FA specialists based on new information to meet FDA reporting requirements Product Complaint & Requirements Analyst Qualifications: Basic knowledge of medical device regulations and industry standards Strong laboratory skills and familiarity with bench methods and equipment Understanding of laboratory instrumentation Knowledge of OSHA, QSR, GLP, ISO, AAMI, and FDA guidelines Broad understanding of manufacturing processes Knowledge of fundamental engineering principles Associate degree in a science-related field Prior laboratory experience preferred ASQ certification (CQE, CQA, CQM, etc.) is a plus Proficiency in MS Excel (pivot tables, VLOOKUP, etc.) 2???3 years of experience in a regulated industry (internships/co-ops acceptable) If you are interested in this Product Complaint & Requirements Analyst position, please apply to this posting with Luke H. at A-Line!