Supplier Quality Engineer
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Job Description
Supplier Quality Engineer supporting Medline’s Supplier Quality operations through audits and performance activities. Partnering cross functionally while developing expertise in supplier quality and regulatory compliance.
Responsibilities:
- 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.
- 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 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.
- Maintain accurate and timely records of supplier audits, performance reviews, nonconformances, and corrective actions.
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).
- ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional preferred.
- Six Sigma Green Belt or higher preferred.
- Supplier quality auditing experience preferred.
- Audit hosting experience preferred.
Benefits:
- Health insurance
- Life and disability insurance
- 401(k) contributions
- Paid time off
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