Quality Engineer - Primary Care

Medline Industries - Winnetka, IL

Part-time - Mid Level

Winnetka, IL

Miscellaneous Manufacturing

About the position

The Quality Engineer is responsible for establishing quality standards and leading efforts in testing, sampling, and training within the production process. This role involves evaluating production processes, recommending improvements, managing vendor quality, and ensuring compliance with regulatory requirements. The engineer will also be involved in product documentation and quality reviews to maintain high standards of product quality and functionality.

Responsibilities

• Manage the development and implementation of methods and procedures for process control, validation, and improvement.
• Design experiments to understand sources of variation affecting products and processes.
• Apply statistical process control (SPC) methods for data analysis to evaluate processes.
• Design and perform experimental product testing and analysis to maintain quality levels.
• Generate and analyze reports on defective products to determine trends and lead corrective actions.
• Direct and collaborate with suppliers on quality problems and ensure corrective action implementation.
• Lead supplier qualifications and contribute to supplier quality improvement programs.
• Provide quality expertise in product development, design control, and risk management.
• Build appropriate product documentation in compliance with regulations.
• Coordinate product testing with internal and external laboratories.
• Ensure compliance with domestic and international regulations associated with product lines.
• Perform quality reviews of design documentation for compliance with requirements.
• Lead investigations of product and process non-conformances and develop corrective and preventive actions.

Requirements

• Bachelor's degree in Engineering, Science, Math, or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience developing ways to accomplish goals with minimal supervision.
• Strong time management skills to prioritize and track details for multiple projects.
• Problem-solving skills to overcome obstacles and reach successful solutions.
• Proficiency in MS Office Suite, especially Microsoft Excel at an intermediate level.
• Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO13485).

Nice-to-haves

• At least 2 years of industry experience in Medical Devices, Drugs, or related fields.

Benefits

• Health and well-being benefits
• Financial fitness programs
• Career development opportunities
• Paid time off
• 401(k) plan participation for part-time employees
• Employee Assistance Program (EAP) access
• Employee Resource Groups (ERG) participation
• Medline Service Corps involvement