Engineer Supplier Management

Medline Industries, LP is a company that supports Supplier Quality operations by executing supplier qualification and performance activities for a global supply base. The role involves conducting supplier audits, supporting supplier qualification activities, and ensuring compliance with FDA regulations and ISO standards.

Responsibilities:

• Conduct supplier audits to verify compliance with ISO 9001, ISO 13485, and applicable regulatory requirements related to high-risk vendors
• Support supplier qualification, requalification, and disqualification activities for moderate to high‑risk suppliers, including documentation review and approval routing
• Review and approve supplier quality records and compliance documentation in accordance with internal procedures
• Execute Supplier Corrective Action Requests (SCARs) by tracking actions, verifying evidence, and documenting effectiveness under supervision
• Assist with supplier communication related to quality requirements, documentation requests, and corrective actions to Medline’s internal business partners and external suppliers
• Provide technical guidance and training to suppliers on quality standards and best practices
• Support containment activities and investigations related to supplier nonconformances
• Utilize root cause analysis and risk management tools to prevent recurrence of issues
• Maintain accurate and timely records of supplier audits, performance reviews, nonconformances, and corrective actions
• Prepare routine reports, dashboards, and summaries for supplier quality performance and compliance tracking

Requirements:

• Bachelor's degree in Engineering, Biology, Quality Management, or related field
• 3–5 years in supplier quality, manufacturing quality, or similar role
• Knowledge of ISO standards, FDA regulations (if applicable), statistical process control (SPC), and quality tools (FMEA, PPAP, APQP)
• Strong communication, problem-solving, and negotiation skills
• Medical Device or drug experience
• Travel up to 25% (domestic and/or international)
• ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional
• Six Sigma Green Belt or higher
• Supplier quality auditing
• Audit hosting experience