Regional Distribution Quality Specialist - Minimed Americas at Medtronic

Lexington, Kentucky, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor's 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
Experience working with 3PL partners and managing quality across multiple sites
Advanced knowledge of quality management systems, regulatory requirements, and industry standards (nice to have)
Experience with deployment of quality systems, issue management, and internal audits (nice to have)
Excellent analytical, problem-solving, and communication skills (nice to have)
Ability to work independently and collaboratively with cross-functional teams, including 3PL partners (nice to have)

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

Skills

ISO 13485

21 CFR 820

GMP

Quality Management Systems

3PL Oversight

Regulatory Compliance

Warehousing

Order Fulfillment

Product Returns

Process Improvement

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

Land your dream remote job 3x faster with AI

Try Jobo Free