Senior Quality Engineer — Medical Device Manufacturing

Cook Group; Bloomington (IN); On-site; USD 75,000 - 90,000; Full time

Job summary

Cook Group is looking for a Quality Engineer in Bloomington, Indiana. This position serves as a lead quality representative, ensuring compliance with internal and external quality standards. The role requires 5-8 years of experience and an engineering degree.

Key responsibilities include managing quality-related issues, supporting product development, and leading continuous improvement efforts. The ideal candidate demonstrates knowledge of medical device regulations and has excellent communication skills.

Qualifications

• 5-8 years of experience in quality engineering.
• Demonstrates ability to adhere to FDA quality requirements.
• Strong organizational skills required.

Responsibilities

• Perform work per external and internal quality standards.
• Interface with internal and external groups on quality-related issues.
• Facilitate development and implementation of production controls.

Skills

Knowledge of medical device regulation (ISO 13485, 21 CFR)

Proficiency in statistical, quality, and continuous improvement methods

Excellent verbal communication skills

Critical thinking and attention to detail

Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook)

Education

Engineering degree

Tools

ASQ or Six Sigma certification

Job description

Cook Group is looking for a Quality Engineer in Bloomington, Indiana. This position serves as a lead quality representative, ensuring compliance with internal and external quality standards. The role requires 5-8 years of experience and an engineering degree.

Key responsibilities include managing quality-related issues, supporting product development, and leading continuous improvement efforts. The ideal candidate demonstrates knowledge of medical device regulations and has excellent communication skills.