Supplier Quality Engineer
Job 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.
Job Description
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
Aid in 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
Minimum Job Requirements
Education: Bachelor’s degree in Engineering, Biology, Quality Management, or related field
Work Experience: 3–5 years in supplier quality, manufacturing quality, or similar role
Knowledge / Skills / Abilities: 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
Preferred Job Requirements
Certification / Licensure: ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional; Six Sigma Green Belt or higher
Experience: Supplier quality auditing; audit hosting experience; medical device or drug experience; travel up to 25%
Pay
The Anticipated Salary Range For This Position: $79,000.00 - $119,000.00 Annual
Schedule
Not specified
Benefits
Medical, dental, vision, life, and disability insurance; 401(k) contributions; paid time off; Employee Assistance Program; Employee Resource Groups; Employee Service Corp.