Quality Engineer II, Medical Devices & Manufacturing

Cook Group; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Cook Group is looking for a Quality Engineer in Bloomington, Indiana. The role involves performing quality work per standards, supporting product development, and interfacing on quality issues. Ideal candidates will have a Bachelor's in engineering, knowledge of medical device regulations, and 3-5 years of experience. Responsibilities also include conducting risk assessments and driving continuous improvement efforts among cross-functional teams.

Qualifications

• 3-5 years of experience in quality engineering.
• Professional certification (e.g. ASQ, Six Sigma) preferred.
• Proficient in quality and continuous improvement methods.

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.
• Conduct risk-based decision making and effective resolution of issues.

Skills

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

Statistical methods and tools

Strong organizational skills

Critical thinking and attention to detail

Excellent verbal communication skills

Education

Bachelor's degree in engineering

Tools

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

Job description

Cook Group is looking for a Quality Engineer in Bloomington, Indiana. The role involves performing quality work per standards, supporting product development, and interfacing on quality issues. Ideal candidates will have a Bachelor's in engineering, knowledge of medical device regulations, and 3-5 years of experience. Responsibilities also include conducting risk assessments and driving continuous improvement efforts among cross-functional teams.