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QSR Auditor I

Key Facts

Remote From: 
Full time
Senior (5-10 years)
English

Other Skills

  • •
    Quality Assurance
  • •
    Innovation
  • •
    Collaboration

Roles & Responsibilities

  • Bachelor's degree in quality, life sciences, engineering, or a related field
  • Knowledge of QSR (FDA 21 CFR Part 820) and/or ISO quality systems
  • Experience with quality audits, CAPA, and documentation
  • Strong analytical, written and verbal communication skills

Requirements:

  • Plan, perform, and document internal and supplier quality system audits to ensure regulatory and QMS compliance
  • Identify nonconformities, communicate findings, and assist in developing corrective and preventive actions (CAPAs)
  • Assist with risk assessments and validation activities as part of quality initiatives
  • Collaborate with cross-functional teams to implement quality improvements and provide training on QMS requirements

Job description

Job Summary

Job Description

About Medine:
Medline is a leading global healthcare company providing quality medical and surgical supplies with superior value throughout North and South America, Europe, Asia and the Middle East. Our ability to create new products, produce less waste and deliver solutions our customers need quickly and cost-effectively is what sets us apart.
Founded in 1910, Medline has grown from a small manufacturer of surgical gowns and uniforms to a thriving global healthcare company driven by an entrepreneurial spirit and strong commitment to its customers. Fifty-four years of consecutive annual growth have led to 2021 sales of more than $20.2 billion worldwide and a stream of new products and services. Medline holds top-tier market share in more than a dozen major medical product categories around the world.

About Medline GSO:
We are Global Sourcing Organization. We provide global procurement, quality assurance, supply chain, marketing and trade compliance services for Medline.

We're 500+ dedicated healthcare professionals across Asia and Latin America. Our focus is on building a robust and sustainable global supply chain to help strengthen Medline's position as a leading provider of healthcare products and services.
Our goal is to deliver the best pricing, quality, availability and innovation through collaboration with our 25+ product divisions, R&D, quality and operations, as well as with our 500+ suppliers across the globe.

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