Validation Engineer I

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.