Quality Engineer 1, Manufacturing

Cook Medical; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Cook Medical is hiring a Quality Engineer 1 for their Bloomington, Indiana location. In this full-time role, you will lead quality initiatives across product development and manufacturing while ensuring compliance with medical device regulations. The ideal candidate will have a Bachelor's degree in a scientific discipline, strong organizational skills, and proficiency in quality improvement methods. This position requires effective collaboration across various teams and adherence to safety protocols.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971).
• Professional certification (e.g. ASQ, Six Sigma) preferred.
• Proficiency in statistical, quality, and continuous improvement methods and tools.
• Strong organizational skills and excellent verbal communication.

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.
• Investigate product nonconformance/complaints and conduct root cause analysis.

Skills

Knowledge of medical device regulation

Proficiency in Microsoft Office

Critical thinking

Strong organizational skills

Excellent verbal communication

Education

Bachelor’s degree in a scientific discipline

Tools

Statistical analysis tools

Quality improvement tools

Job description

Quality Engineer 1, Manufacturing

Requisition ID: 2026-18159
Posting Date: 6 hours ago (3/19/2026 11:00 AM)
Location: Bloomington, IN, United States
Job 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

• Bachelor’s degree in a scientific discipline or equivalent experience


• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)


• 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

“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.