Quality Engineer II - CAPA, Risk & Process Control

Regulatory Jobs; 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

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