Regional Distribution Quality Specialist – Minimed Americas

About Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.

Job Summary

The Regional Distribution Quality Specialist is responsible for ensuring the quality of distribution operations across the Americas, focusing on warehousing, order fulfillment, product returns, and value-added services such as labeling, boxing and recharging.

Key Responsibilities

• Develops and maintains quality programs, systems, processes, and procedures to ensure compliance with GMP, ISO 13485, and 21 CFR 820 regulations for distribution operations across 3PL partners in the Americas.
• Provides expertise and guidance on quality and regulatory requirements for distribution operations, ensuring compliance with regional and global standards.
• Collaborates with cross-functional teams, including 3PL partners, to analyze and improve processes, systems, and procedures for distribution operations, focusing on issue management and continuous improvement.
• Supports internal audits and assessments of 3PL partners to ensure compliance with regulatory requirements and company standards.
• Prepares reports and necessary documentation (e.g., Corrective and Preventive Actions) and provides to applicable stakeholders, both internal and external.
• Ensures quality assurance programs and policies are maintained and modified regularly to reflect changes in distribution operations and regulatory requirements.
• Facilitates uniform standards and enables best practice sharing across the distribution centers based on Medtronic Minimed requirements.

Requirements

• Bachelors degree (or equivalent) in a relevant field (e.g., quality management, supply chain, logistics, pharmaceuticals).
• Minimum 4 years of relevant experience in quality management, distribution operations, or a related field, with a focus on GMP, ISO 13485, and 21 CFR 820 regulations.