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Quality Data Analyst

Company: Cook Group
Location: Bloomington
Posted on: September 21, 2022

Job Description:

Work with subject matter experts, process owners, subsystem leaders, management with executive responsibilities, and IT to execute quality system planning, processes, verification, analysis, and reporting methods while promoting a collaborative atmostphere of quality awareness and continuous improvement.

- Support quality system activities as they relate to quality data, data analytics, and trending.- Perform analysis of data in support of quality data trending. Additional analyses of data may be required as needed by the subsystems throughout CINC, e.g. Risk Management, Complaint Handling, CAPA.- Collaborate with data stewards and process owners to identify data needs and develop dashboards to support processes within COOK's Quality Management System. - Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and COOK's Quality Management System, where applicable. - General research, documentation, and file/database maintenance.- Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Working knowledge and understanding of COOK Medical Management System Procedures, e.g. CAPA, Nonconformances, Calibration. - Working knowledge and understanding of ISO 13485 regulations and FDA 21 CFR 820 Quality System Regulations.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Relevant experience in Quality Assurance or Data Analytics.- Bachelor's Degree or equivalent in a technical discipline or experience of such kind and amount as to provide a comparable background.- Working knowledge of medical device regulations, including pertinent standards and guidances, preferred or demonstrated regulatory knowledge in similarly regulated industry.- Knowledge of Cook Inc. quality system, associated documentation, and product lines preferred or demonstrated medical device (or similar industry) quality system knowledge.- Experience in statistical and analytical reasoning preferred.- Computer literacy and proficiency.- Data analysis software experience preferred (e.g. Minitab, JMP, etc.) -Physical Requirements:--- Works under general office environment conditions--- Sitting for extended periods--- Utilizes close visual acuity for working with computers and equipment--- Frequently required to stand, walk, and communicate--- Frequently required to lift between 20 and 50 pounds throughout the workday--- Travel up to 30%

Keywords: Cook Group, Bloomington , Quality Data Analyst, Professions , Bloomington, Indiana

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