Senior Quality & Regulatory Leader for Medical Devices

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 department(s), adapting plans to address resource and operational challenges.

You will collaborate with divisions, suppliers, manufacturing and operations to ensure quality products and customer satisfaction; oversee complaints, drive continuous improvement, and support design, testing, inspections and validations to uphold QSR, GMP, ISO requirements.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 4+ years of experience designing/operating medical device or drug product platforms with compliance.
• Broad knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDR and related standards.
• Strong data analysis to identify issues and drive improvements.
• Advanced Microsoft Excel skills (PivotTables, data analysis, etc.).

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations.
• 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 validations to assure quality products or components.
• Ensure quality issues are resolved to customer satisfaction in a timely manner.
• Interface with internal and external customers to resolve issues.

Skills

Regulatory compliance

Data analysis

Advanced Excel

Project coordination

Education

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

Tools

Microsoft Excel

Job description

Medline Industries, LP seeks a quality and regulatory leader to manage quality and compliance for assigned department(s), adapting plans to address resource and operational challenges.

You will collaborate with divisions, suppliers, manufacturing and operations to ensure quality products and customer satisfaction; oversee complaints, drive continuous improvement, and support design, testing, inspections and validations to uphold QSR, GMP, ISO requirements.