Risevoic
Quality Engineer 2, Manufacturing
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 3 January 2026
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 Biomedical Engineering, Mechanical Engineering, Industrial Engineering,
• 3-5 years of 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
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Frequently asked questions
In Bloomington, certifications like ASQ's Certified Quality Engineer and Six Sigma are highly valued for Quality Engineer 2 roles. They demonstrate mastery of quality systems and risk management, aligning well with manufacturing standards and medical device regulations in the local industry.
Cook Medical attracts strong candidates for Quality Engineer 2 roles due to its reputation in medical device manufacturing. The local job market features moderate competition, with applicants needing solid engineering experience and knowledge of ISO 13485 and FDA regulations to stand out.
Quality Engineer 2 professionals often juggle complex investigations into product nonconformance, coordinating cross-functional teams, and ensuring compliance with stringent quality standards. Managing risk assessments and facilitating continuous improvements are frequent hurdles requiring strong analytical skills.
Advancement for Quality Engineer 2 specialists typically involves progressing toward managerial positions or specializing in regulatory affairs and risk management. Opportunities to lead CAPA initiatives and cross-departmental projects can accelerate skill development and leadership exposure.
Cook Medical emphasizes integration of quality engineering with medical device regulations like ISO 13485 and 21 CFR, requiring a deeper understanding of healthcare compliance. The role blends technical expertise with collaboration across clinical and regulatory teams, setting it apart from general manufacturing roles.
Cook Medical equips their Quality Engineer 2s with robust cross-functional collaboration frameworks and continuous improvement programs. Access to internal audits and third-party regulatory interactions enhances their ability to resolve quality challenges effectively and maintain compliance.
Quality Engineer 2 roles in Bloomington typically offer salaries between $75,000 and $90,000 annually, reflecting the specialized expertise required in medical device manufacturing and quality systems. Compensation can vary based on experience, certifications, and specific company benefits.
Bloomington's moderate traffic and accessible industrial zones mean commuting to manufacturing sites like Cook Medical is generally manageable. However, proximity to the facility can improve work-life balance, especially given occasional onsite demands in manufacturing and biohazard lab settings.
Proficiency with statistical tools, process validation techniques, and risk management standards such as ISO 14971 is critical. Familiarity with Microsoft Office for reporting and strong root cause analysis capabilities also empower Quality Engineer 2s to excel in manufacturing quality oversight.
By actively engaging with production, clinical, and regulatory teams, a Quality Engineer 2 can identify process improvements, address compliance gaps, and streamline CAPA processes. This collaborative approach fosters a culture of continuous quality enhancement essential in medical device manufacturing.