QA & Regulatory Risk Manager

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Quality and Regulatory Leader to manage quality and compliance for assigned product lines. The role adapts plans to resource and operational challenges across departments.

Responsibilities include ensuring regulatory compliance, coordinating with divisions and suppliers, managing complaints, and driving continuous improvement initiatives. Travel up to 25% may be required.

Qualifications

• Broad knowledge of regulatory standards (21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR).
• Ability to analyze data to identify trends and drive improvements.
• Experience coordinating multiple projects with deadlines and stakeholders.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO) for product lifecycle and distribution regions.
• Coordinate with Divisions, Suppliers, Manufacturing, and Operations to assure quality products and customer satisfaction.
• Manage complaints and develop new approaches to investigation-based problems.
• Identify and lead continuous improvement projects.
• Assist in product evaluation from QA and regulatory compliance perspectives.
• Help plan design, testing, inspection, and process validations to ensure quality.
• Resolve quality issues to customer satisfaction in a timely manner.
• Interface with internal and external customers to resolve production quality issues.
• Oversee staff performance, budgets, and policy interpretation for departments.

Skills

Regulatory compliance

Excel proficiency

Quality Assurance

Education

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

Job description

Medline Industries, LP seeks a Quality and Regulatory Leader to manage quality and compliance for assigned product lines. The role adapts plans to resource and operational challenges across departments.

Responsibilities include ensuring regulatory compliance, coordinating with divisions and suppliers, managing complaints, and driving continuous improvement initiatives. Travel up to 25% may be required.