Engineering Program Director - Americas Distribution Quality Operations

Medtronic•Memphis, TN

5d•Onsite

About The Position

The Engineering Program Director, Distribution Quality Operations for Americas is responsible for leading and executing complex global quality programs that support distribution operations and operating unit requirements. This role serves as the primary program manager for Americas product rework initiatives, cosmetic fix programs, Product Hold Order (PHO) activities, and distribution supplier quality oversight. The position requires strong cross-functional leadership to coordinate activities across Operating Units, Distribution Centers, Supply Chain, Regulatory Affairs, Manufacturing, Quality, and third-party logistics partners. The Program Director ensures programs are executed in compliance with quality system requirements, regulatory expectations, and business objectives while driving efficient product disposition and distribution continuity.

Requirements

Requires a Bachelors degree in Engineering or Technical Sciences with 10 years of relevant work experience in Supplier Quality Execution and Project Management in a highly regulated industry and 7+ years of managerial experience, OR advanced degree in Engineering or Technical Sciences with 8 years of relevant work experience in Supplier Quality Execution and Project Management in a highly regulated industry and 7+ years of managerial experience

Nice To Haves

PMP, Lean Six Sigma, or equivalent project management certification.
Experience supporting distribution center operations, field actions, product recalls, or product hold activities.
Knowledge of FDA, ISO 13485, and medical device regulatory requirements.
Experience with supplier quality management and third-party logistics oversight.
Demonstrated ability to lead global, cross-functional teams in a matrix environment.

Responsibilities

Lead and execute global quality programs supporting cosmetic fixes, product rework activities, relabeling initiatives, and other supporting activities.
Develop and manage program plans, timelines, budgets, risks, and stakeholder communication strategies.
Coordinate cross-functional teams to ensure program deliverables are completed on schedule and meet quality and regulatory requirements.
Establish governance processes and provide regular status updates to senior leadership and operating unit stakeholders.
Facilitate issue resolution and escalation management for critical program risks and barriers.
Partner with Operating Units to define, document, and drive approvals of business, quality, and regulatory requirements for product rework and cosmetic fix activities.
Lead change control activities associated with global distribution and rework initiatives.
Ensure documentation packages, risk assessments, validation requirements, and implementation plans are completed and approved in accordance with Quality System requirements.
Support development and maintenance of procedures, work instructions, and program documentation.
Lead execution of Product Hold Orders affecting Americas Distribution sites.
Coordinate inspection, sampling, segregation, containment, disposition, rework, scrapping, and shipment activities.
Ensure PHO activities are executed in accordance with approved procedures, regulatory requirements, and operating unit instructions.
Facilitate communication between operating units, distribution centers, quality teams, and supply chain stakeholders.
Provide reporting and status updates on hold order progression, product disposition decisions, and completion activities.
Oversee supplier quality activities supporting distribution operations, including third-party logistics providers, repackaging suppliers, and service providers.
Coordinate supplier assessments, audits, performance reviews, and quality improvement initiatives that will be executed by Quality Engineering.
Monitor supplier quality metrics and identify opportunities to reduce risk and improve performance.
Coordinate logistics activities associated with product rework, relabeling, inspection, and product disposition programs.
Collaborate with manufacturing and logistics partners to execute approved plans.
Ensure inventory movement, product accountability, and traceability requirements are maintained throughout program execution.
Monitor program performance metrics and implement corrective actions as necessary.
Assess project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.