Regulatory Quality Manager, Medical Devices

Medline Industries, Inc.; Chicago (IL); Presencial; USD 116.000 - 174.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Life and disability

401(k) contributions

Paid time off

Descripción de la vacante

Medline Industries, LP in Chicago is seeking a qualified professional to manage quality and regulatory compliance for assigned product lines, adapting plans to address resource and operational challenges across the life cycle.

You will lead regulatory activities, liaise with divisions, suppliers and manufacturing to ensure quality products and customer satisfaction, manage complaints, drive continuous improvement, and support design controls, testing and process validations.

Formación

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field, or relevant experience.
• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• Broad knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Proficiency in analyzing data to identify issues and drive improvements.
• Travel up to 25% of time for business purposes.

Responsabilidades

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP, ISO) pertaining to the product lifecycle and distribution regions.
• Liaise 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 execution of continuous improvement projects.
• Assist in planning design, testing, inspection, and process validations to assure quality products.
• Ensure all quality issues are resolved to customer satisfaction in a timely manner.
• Resolve quality issues by interfacing with internal and external customers.

Conocimientos

Regulatory compliance knowledge

Data analysis

Project coordination

Excel skills

Travel readiness

Educación

Bachelor’s degree in Engineering/Science/Technical Field

Descripción del empleo

Medline Industries, LP in Chicago is seeking a qualified professional to manage quality and regulatory compliance for assigned product lines, adapting plans to address resource and operational challenges across the life cycle.

You will lead regulatory activities, liaise with divisions, suppliers and manufacturing to ensure quality products and customer satisfaction, manage complaints, drive continuous improvement, and support design controls, testing and process validations.