[Hiring] Supplier Quality Engineer @Medline Industries, LP

Role Description

Support Medline’s Supplier Quality operations by executing supplier qualification, monitoring, and performance activities for a global supply base. This role assists with supplier assessments, documentation review, audits, and issue resolution to ensure compliance with FDA regulations, ISO standards, and internal quality system requirements. The position partners cross functionally while developing foundational expertise in supplier quality and regulatory compliance.

• Conduct supplier audits to verify compliance with ISO 9001, ISO 13485, and applicable regulatory requirements related to high-risk vendors.
• Support supplier qualification, re‑qualification, 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.

Qualifications

• 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).

Requirements

• ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional.
• Six Sigma Green Belt or higher.
• Supplier quality auditing.
• Audit hosting experience.

Benefits

• Health insurance.
• Life and disability insurance.
• 401(k) contributions.
• Paid time off.
• Access to the Employee Assistance Program.
• Access to Employee Resource Groups.
• Access to the Employee Service Corp.