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Engineer Supplier Quality

Role overview

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), SPC, and quality tools (FMEA, PPAP, APQP).
  • Strong communication, problem-solving, and negotiation skills.

Responsibilities

  • Conduct supplier audits to verify ISO 9001, ISO 13485, and applicable regulatory requirements for 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.

About the company

Medline Industries, LP logo

Medline Industries, LP

Medical Devices & Equipment

Medline is a healthcare company–a manufacturer, distributor and so much more, doing business in more than 125 countries and territories around the world. We provide the quality medical products and solutions our customers need to deliver their best care to every person in every care setting. Together, we free up the clinical and supply chain resources required to improve the overall operating performance of healthcare. In a complex healthcare world, Medline strives to help our customers achieve both clinical and financial success. We do that through a personalized approach to listen and better understand our customers’ needs in an environment that tirelessly demands lower costs and better outcomes. Our responsiveness and commitment to making healthcare run better is evident in our actions every day. This is who we are. This is why customers choose us as their trusted, integrated business partner.

Company details

Company typeXLarge
IndustryMedical Devices & Equipment
Company size10001

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Job description

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

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

Travel up to 25% (domestic and/or international)

PREFERRED JOB REQUIREMENTS

Education

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

Knowledge / Skills / Abilities

DISCLAIMER

All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.

This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s).

This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.

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 a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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