Quality Engineer

Job Title

Quality Engineer

Cleveland, OH

12+ Months

1st Shift – 8 AM to 5 PM, 5 days a week.

Temporary position (currently).

Video interview followed by in‑person on‑site interview.

• Evaluate and control product and service quality.
• Work cross‑functionally in the development and/or maintenance of products or services.
• Resolve equipment and process‑related production issues.
• Perform activities including equipment, process, materials, and method validation.
• Conduct statistical analysis and metrics to analyze systems and processes.
• Apply basic statistical sample size calculations to work for quality determination on simple projects.
• Write test protocols, conduct tests, collect data, and write reports to validate plans.
• Support quality system improvements and maintenance through change control, process improvements, and compliance risk reduction.
• Support projects and daily quality tasks such as complaints, non‑conforming materials investigations, etc.
• Demonstrate basic knowledge of theories, practices, and procedures in the job family or skill set; apply knowledge and skills to complete own work while developing competence.

• 3–5 years of quality experience (preferred).
• Technical background; bachelor’s degree preferred.
• Basic knowledge of quality engineering policies, principles, and best practices.
• Basic knowledge of FDA/ISO requirements.
• Basic understanding of regulatory requirements such as cGMP, FDA, ISO, etc.
• Basic statistical sample size calculation knowledge.
• Ability to work independently under guidance and to develop competence in own area.
• Desire to support quality system improvements and maintain compliance.