Quality Engineer 2, Manufacturing

Regulatory Toolkit; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Cook Inc. is seeking a Quality Engineer to act as the lead quality representative for select product lines across development, manufacturing, and post-market activities. This role supports CAPA, risk management, and production controls while ensuring adherence to medical device regulations.

The ideal candidate has a engineering degree, 3–5 years of experience, and certifications like ASQ or Six Sigma. Strong analytical skills and proficiency with MS Office are required to drive continuous

Qualifications

• Bachelor's degree in engineering.
• Legally authorized to work in the United States; no visa sponsorship provided.
• Knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).
• 3–5 years of experience.
• Professional certification (e.g., ASQ, Six Sigma) preferred.
• Proficiency in statistical, quality and continuous improvement methods and tools.
• MS Office suite (Word, Excel, PowerPoint, Outlook) required.
• Strong organizational skills, attention to detail, and critical thinking.
• Excellent verbal communication and technical writing.

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 (qualification, process capability, sampling plans, validation).
• Investigate nonconformances/complaints, perform root cause analyses, monitor trends, escalate issues.
• Plan, review, and approve change requests.
• Execute risk assessment and maintain risk file documentation.
• Conduct risk-based decision making and issue resolution.
• Lead or support CAPAs as necessary.
• Interface with audits (FDA, Notified Body, etc.) as needed.
• Drive continuous improvement with cross-functional teams (quality, engineering, production, clinical, regulatory).
• Provide leadership in understanding medical device regulations and best practices.
• Manage conflict resolution in technical situations.
• Interact professionally across organizational levels and adhere to safety requirements.

Skills

Organizational skills

Critical thinking

Verbal communication

Technical writing

MS Office proficiency

Statistical methods

Education

Bachelor's degree in engineering

Tools

Six Sigma

Job description

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 withcomputers, equipment, etc.
• Occasional travel may be required