Validation Engineer I

Job title: Validation Engineer I

About the Role Summary: 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.

What You'll Do

• 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.

What We're Looking For

• Education: Bachelor's degree in Engineering, Biology, Quality Management, or related field.
• Certification / Licensure: ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional (preferred).
• Work Experience: 3-5 years in supplier quality, manufacturing quality, or similar role.
• Knowledge / Skills / Abilities: Knowledge of ISO standards, FDA regulations (if applicable), SPC, and quality tools (FMEA, PPAP, APQP). Strong communication, problem-solving, and negotiation skills.
• Travel: Up to 25% (domestic and/or international).

Nice to Have

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

Compensation & Benefits

• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles with less than 30 hours per week, benefits include 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
• Medline is an equal opportunity employer. We value diversity and belonging.