We anticipate the application window for this opening will close on - 28 Nov 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

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. This role will provide quality support and oversight to ensure compliance with internal and external regulations, standards, and guidelines, specifically ISO 13485, and 21 CFR 820, across multiple 3PL distribution centers in the Americas in support of Medtronic Minimed.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

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.

Must Have:

• 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.
   

Nice to Have:

• Advanced knowledge of quality management systems, regulatory requirements, and industry standards

• Experience with deployment of quality systems, issue management, and internal audit experience

• Excellent analytical, problem-solving, and communication skills.

• Ability to work independently and collaboratively with cross-functional teams, including 3PL partners
   

Differentiating Factors:

• Autonomy: Works independently under limited supervision to determine and develop approach to solutions

• Organizational Impact: Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments

• Innovation and Complexity:

• Analyzes complex problems and provides recommendations on process improvements

• Communication and Influence: Communicates with internal and external customers, vendors, and stakeholders to achieve objectives and influence decision-making

Additional Requirements:

• Experience working with 3PL partners and managing quality across multiple sites

• Strong understanding of the medical device industry and regulatory requirements

• Ability to travel to 3PL sites and other locations as needed

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job