Quality Assurance Manager - ReadyCare

Medline Industries - Winnetka, IL

Part-time - Mid Level

Winnetka, IL

Miscellaneous Manufacturing

About the position

The position is responsible for managing quality and compliance for products and processes within assigned departments. The role involves adapting departmental plans to address operational challenges and ensuring adherence to regulatory standards.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP, ISO) for the product life cycle and distribution regions.
• Act as a liaison with Divisions, Suppliers, Manufacturing, and Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during investigations.
• Identify and manage the execution of continuous improvement projects.
• Assist in product evaluation from a quality assurance and regulatory compliance standpoint.
• Plan design, testing, inspection, and process validations to assure quality products or components.
• Resolve quality issues to customer satisfaction in a timely manner.
• Interface with internal and external customers to resolve product or production quality issues.
• Oversee day-to-day operations of a group of employees, including hiring, training, and performance reviews.

Requirements

• Bachelor's degree in Engineering, Science, or Technical Field.
• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, including compliance with QSR/GMP/ISO requirements.
• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• Proficiency in analyzing and reporting data to identify issues and drive improvements.
• Demonstrated ability to manage concurrent projects and meet critical deadlines.
• Advanced level skill in Microsoft Excel.

Nice-to-haves

• At least 2 years of supervisory/managerial experience.
• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Benefits

• Health and well-being benefits for employees working at least 30 hours per week.
• Financial fitness programs.
• Career development opportunities.
• Paid time off.
• 401(k) plan access for employees working less than 30 hours per week.
• Employee Assistance Program (EAP) access.
• Participation in Employee Resource Groups (ERG) and Medline Service Corps.