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Overview
The Quality Manufacturing Engineer at Cook Incwill spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing The Quality Engineer serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
Responsibilities
• Performance of risk assessments, internal product and process non-conformances, quality investigations, independent projects and containment activities• Support/asses/develop continual improvement activities in response to non-conformances and other quality data metrics• Review/approve validations, test methods, protocols, monthly non-conformance reports, change requests, risk management files and other documents• Own or assist with internal investigations and CAPA's• Work with Quality Assurance and Production Engineering to verify/validate critical processes/products and apply control mechanisms around those processes/products so they can be effectively monitored• Trending of data and data analysis• Ensure compliance to quality system policies & department procedures• Maintain accurate timely reports and records
Qualifications
• Bachelor's degree in Engineering or related technical field; at least 5 years of experience in Quality Engineering, Manufacturing Engineering or Development Engineering• Knowledge of medical device regulations, pertinent standards and guidances• Knowledge of quality tools and principles
• Experience in project management and managing multiple activities preferred
Requisition ID2025-16246
Posting Date6 days ago(3/12/2025 2:05 PM)
Job Location(s)Bloomington IN United States
Job LocationsUS-IN-Bloomington
TravelLess than 10%
Position TypeFull Time
CompanyCook Inc - Bloomington
CategoryQuality