Job Description

MAJOR 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, 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.

MINIMUM JOB REQUIREMENTS

Education

Bachelor’s degree in Engineering, Biology, Quality Management, or related field.

Certification / Licensure

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

Certification / Licensure

ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional.

Six Sigma Green Belt or higher.

Work Experience

Supplier quality auditing
Audit hosting experience

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.