Quality Engineer 2, Manufacturing at Cook Group, Bloomington, IN

Quality Engineer 2, Manufacturing at Cook Group in Bloomington, IN. Full-time. Est. up to $130k. Apply with swipeandhired.

Requisition ID 2026-18160 Posting Date 7 months ago (3/19/2026 11:00 AM) Job Location(s) Bloomington IN United States Job Locations US-IN-Bloomington Position Type Full Time Company Cook Inc - Bloomington Category Quality Overview The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Responsibilities • Perform work per external and internal quality standards • Interface with internal and external groups on quality-related issues • Support product development and transfer to manufacturing • Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.) • Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues • Plan, review, and approve change requests • Execute risk assessment as needed and facilitate development and completion of risk file documentation • Conduct Risk-based decision making and effective resolution of issues • Lead or support CAPAs as necessary • May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.) • Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs. • Provide leadership in the understanding of medical device regulations and best practices • Manage conflict resolution as it relates to technical situations • Must work and interact effectively and professionally with and for others throughout various levels of the organization • Must strictly adhere to safety requirements Qualifications • Bachelors degree in engineering • Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. • Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971) • 3-5 years of experience • Professional certification (e.g. ASQ, Six Sigma, etc.) preferred • Proficiency in statistical, quality and continuous improvement methods and tools • Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required. • Strong organizational skills • Critical thinking and attention to detail required • Excellent verbal communication skills and technical writing Physical Requirements: • Works under general office environmental conditions, including time in manufacturing environment and biohazard lab • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc. • Occasional travel may be required