Regional Distribution Quality Specialist - Minimed Americas at Medtronic
Medtronic · Lexington, United States Of America · Hybrid
- Professional
- Office in Lexington
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 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
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: 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).
The following benefits and additional compensation are available to all regular employees: 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).
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
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
