Regional Distribution Quality Specialist - Minimed Americas

Medtronic • Los Angeles, CA

4d • $89,600 - $134,400

About The Position

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.

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.

Nice To Haves

• 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
• 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

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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees