Quality & Compliance Manager, Medical Devices

Medline Industries, LP; Chicago (IL); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee training & development

Job summary

Medline Industries, LP is seeking a quality and regulatory professional to oversee quality and compliance for assigned products and processes. You will adapt departmental plans to meet resource and operational challenges while coordinating with divisions, suppliers, manufacturing, and operations.

You will manage complaints, drive continuous improvement, and support design and process validations to ensure customer satisfaction and regulatory compliance across the product lifecycle.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field required.
• 4+ years of experience in design/operation of medical device or drug product platforms with QSR/GMP/ISO experience.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDR and related standards.
• Proficiency in analyzing data to identify issues and drive improvements.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO) for product lifecycle and distribution regions.
• Act as liaison with divisions, suppliers, manufacturing, and operations to assure quality products and customer satisfaction.
• Manage complaints and develop new approaches to resolve investigations.
• Identify and execute continuous improvement projects.
• Assist in product evaluation from a quality assurance and regulatory compliance standpoint.
• Assist in planning design, testing, inspection, and process validations to assure quality.
• Resolve quality issues to customer satisfaction in a timely manner.
• Interface with internal and external customers to address product or production quality issues.

Skills

Quality assurance

Regulatory compliance

Data analysis

Excel advanced

Education

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

Tools

Microsoft Excel

Document control software

Job description

Medline Industries, LP is seeking a quality and regulatory professional to oversee quality and compliance for assigned products and processes. You will adapt departmental plans to meet resource and operational challenges while coordinating with divisions, suppliers, manufacturing, and operations.

You will manage complaints, drive continuous improvement, and support design and process validations to ensure customer satisfaction and regulatory compliance across the product lifecycle.