Regional Distribution Quality Specialist - Minimed Americas

Regional Distribution Quality Specialist

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.

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.

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 :

Nice to Have :

Differentiating Factors :

Additional Requirements :

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week :

The following benefits and additional compensation are available to all regular employees :

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below :

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.