Quality & Regulatory Risk Lead (QA, ISO, QMS)

Medline Industries, Inc. in; Northfield Township (IL); Sur place; USD 116 000 - 174 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Résumé du poste

Medline Industries, LP is hiring for a senior role focused on quality and regulatory compliance for medical products and processes. You will adapt departmental plans to address resource and operational needs while ensuring adherence to QSR, GMP, ISO and MDR standards.

Responsibilities include coordinating with divisions, suppliers, and operations to guarantee product quality and customer satisfaction, managing investigations of complaints, and driving continuous improvement projects across

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field or relevant experience.
• At least 4 years of experience in design/operation of medical device or drug product platforms with design controls, risk management and compliance.
• Broad knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR; ability to analyze data and drive improvements.
• Travel up to 25% of the time (domestic and international).

Responsabilités

• Ensure quality and regulatory compliance with applicable regulations for product life cycle and distribution regions.
• Coordinate with Divisions, Suppliers, Manufacturing, and Operations to ensure quality and customer satisfaction.
• Manage complaints and develop solutions from investigations.
• Lead continuous improvement projects and process validations for quality.
• Assist in product evaluation from QA and regulatory perspectives.
• Plan design, testing, inspection, and process validations to assure quality.

Connaissances

Regulatory knowledge (QSR/GMP/ISO)

Data analysis

Project management

Formation

Bachelor’s degree in Engineering, Science, or Technical Field

Outils

Microsoft Excel

Description du poste

Medline Industries, LP is hiring for a senior role focused on quality and regulatory compliance for medical products and processes. You will adapt departmental plans to address resource and operational needs while ensuring adherence to QSR, GMP, ISO and MDR standards.

Responsibilities include coordinating with divisions, suppliers, and operations to guarantee product quality and customer satisfaction, managing investigations of complaints, and driving continuous improvement projects across