Manufacturing Quality Engineer 1 (Finance)
Manufacturing Quality Engineer 1
Requisition ID 2025-16246
Posting Date 10 hours ago (3/12/2025 2:05 PM)
Job Location(s) Bloomington IN United States
Job Locations US-IN-Bloomington
Travel Less than 10%
Position Type Full Time
Company Cook Inc - Bloomington
Category Quality
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
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
