QA Risk & Compliance Manager

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

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a senior quality and regulatory leader to manage quality and compliance for assigned product areas. The role adapts departmental plans to meet resource and operational challenges.

You will coordinate with divisions, suppliers, manufacturing, and operations to ensure high-quality products and customer satisfaction while driving continuous improvement. Travel up to 25% is expected, and a Bachelor’s degree plus 4+ years in regulated medical device or drug product

Qualifications

• Bachelor’s degree in engineering, science, or technical field, or relevant experience.
• At least 4 years in design/operation of medical device or drug product platforms with QSR/GMP/ISO compliance.
• Broad knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Excel proficiency including pivot tables and data analysis.
• Willingness to travel up to 25% for business purposes.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO) across product life cycle and regions.
• Liaise with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction.
• Manage complaints and develop approaches to solve issues identified in investigations.
• Identify and manage execution of continuous improvement projects.
• Assist in product evaluation from QA and regulatory perspectives and plan design, testing, inspection, and validations.
• Ensure all quality issues are resolved to customer satisfaction in a timely manner.
• Resolve issues related to product or production quality by interfacing with internal and external customers.

Skills

Regulatory compliance

Quality management

Data analysis

Excel

Project coordination

Education

Bachelor’s degree in Engineering/Science/Technical Field

Job description

Medline Industries, LP is seeking a senior quality and regulatory leader to manage quality and compliance for assigned product areas. The role adapts departmental plans to meet resource and operational challenges.

You will coordinate with divisions, suppliers, manufacturing, and operations to ensure high-quality products and customer satisfaction while driving continuous improvement. Travel up to 25% is expected, and a Bachelor’s degree plus 4+ years in regulated medical device or drug product