Medline Industries
Jobs at Medline Industries
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Leads daily manufacturing operations, production output, safety, quality, staffing, and continuous improvement. Coordinates plant activities across operations, engineering, procurement, shipping, maintenance, quality, and technology teams. Implements lean initiatives to improve productivity, reduce scrap, downtime, and costs. Develops employees, manages performance, resolves customer quality issues, maintains compliance with quality systems, and performs root cause analysis.
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Supervise laboratory technicians conducting chemical and microbiological testing of raw materials, in-process materials, finished goods, stability samples, and project work. Ensure compliance with FDA, ISO, ICH, GMP, and medical device requirements. Lead investigations, corrective actions, technical documentation, SOP development, training, process improvement, regulatory interactions, staffing, performance management, and laboratory budgeting.
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Performs routine laboratory testing of raw materials, in-process materials, finished goods, and stability samples according to standard operating procedures. Documents test data and results, reviews calculations for accuracy, maintains laboratory equipment, identifies malfunctions, coordinates repairs, updates procedures, follows laboratory safety and documentation practices, and communicates scientific results.
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Supports product recall activities by responding to customer and internal inquiries, coordinating recalled product returns, issuing return documentation, managing sub-recall notifications, maintaining compliance records, collaborating with vendors and Quality teams, and ensuring affected products are identified, segregated, and secured according to FDA regulations and internal procedures.
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Leads medical device quality engineering activities, including process validation, testing, statistical analysis, supplier quality, design controls, risk management, regulatory documentation, CAPA, and nonconformance investigations. Maintains Device Master Records, product specifications, design control files, and CE technical files, while supporting 510(k) submissions and regulatory compliance. Provides cross-functional leadership, training, and quality expertise with up to 15% travel.
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Leads quality assurance strategy and operations for assigned manufacturing divisions, ensuring compliance with FDA, EU MDR, cGMP, and other regulations. Oversees staff development, quality systems, new product and supplier qualification, training programs, procedural changes, and cross-functional communication. Requires substantial QA and people-management experience, with travel up to 20%.
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Plans, coordinates, and delivers training and development for QA, QC, and Regulatory Affairs staff. Conducts needs analyses, develops and updates training curricula and materials, provides onboarding and hands-on instruction, verifies training effectiveness, and partners with plants and subject-matter experts. Delivers company-wide cGMP, ISO, and QSR training while supporting new hires and addressing departmental training needs.
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Leads the Sustaining Quality organization, developing strategy and governance for product lifecycle quality, remediation, CAPA, risk management, audit readiness, and quality system improvement. Oversees cross-functional programs, regulatory compliance, executive reporting, resource allocation, budgets, and multiple managers. Requires strong knowledge of medical device and pharmaceutical quality standards, data analysis, program management, and senior-level communication. Travel up to 30% is required.
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Leads quality engineering activities for medical device and regulated products, including process validation, testing, statistical analysis, supplier qualification, design controls, risk management, technical files, and regulatory compliance. Investigates nonconformances, drives CAPA and SCAR actions, supports 510(k) submissions, maintains product documentation, and trains cross-functional teams. Requires independent work, leadership, advanced Excel skills, and up to 15% travel.
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Leads quality engineering activities for medical device products, including process validation, testing, statistical analysis, supplier quality, design controls, risk management, technical files, and regulatory compliance. Directs nonconformance investigations, CAPA, SCARs, corrective actions, product documentation, and supplier qualifications. Collaborates with regulatory teams and laboratories, trains employees, and serves as quality lead when needed. Requires at least four years of quality or engineering experience and up to 15% travel.
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Leads Quality Assurance strategy and operations across assigned product divisions, ensuring compliance with FDA, EU MDR, cGMP, and other regulations. Oversees QA teams, staffing, training, performance management, product development quality, supplier qualification, process changes, and quality systems. Coordinates with corporate and divisional leadership while supporting new products, services, customers, and vendors. Requires at least seven years of QA experience, five years managing people, and up to 20% business travel.
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Provides enterprise leadership for a global Quality Management System, including governance, process harmonization, post-market surveillance, quality technology, analytics, AI, and automation. Establishes strategy, metrics, accountability, and compliance across global sites and business units. Leads senior quality leaders, drives organizational capability, partners cross-functionally, and ensures sustainable adherence to FDA, ISO, EU MDR, and other global requirements. Requires extensive executive experience in quality, regulatory affairs, or another highly regulated industry, with travel up to 50%.
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Leads product quality and compliance for medical device and drug combination product platforms. Directs quality teams, develops product specifications and QA strategies, oversees supplier and audit activities, ensures FDA, QSR, GMP, ISO, MDSAP, and MDR compliance, and partners with senior leadership, suppliers, manufacturing, and product teams. Manages multiple managers, budgets, staffing, strategic planning, and customer presentations. Requires up to 30% business travel.
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Develops and implements quality control, validation, testing, inspection, and process improvement methods for medical device products. Analyzes process variation and defects using statistical quality control, leads corrective and preventive actions, manages supplier quality activities, and supports product development, design controls, risk management, regulatory submissions, and CE technical files. Ensures compliance with domestic and international quality regulations and maintains product documentation.
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Leads manufacturing quality teams and develops quality strategies for medical device and combination-product operations. Oversees product specifications, supplier quality, QA programs, QSR compliance, audits, and FDA/ISO requirements. Partners with suppliers, manufacturing, operations, product managers, customers, and senior leadership to ensure compliant products and on-time delivery. Manages multiple managers, budgets, staffing, performance, policies, and long-term departmental planning. Requires travel up to 30%.
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Leads global CAPA, Nonconformance, and Deviation strategy, governance, infrastructure, reporting, and continuous improvement. Establishes enterprise standards, review boards, escalation criteria, and consistent execution across global sites and business units. Oversees root cause investigations, corrective action effectiveness, risk mitigation, regulatory compliance, and systemic trend reporting. Builds organizational capability through training and coaching while leading cross-functional quality-system initiatives.
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Leads quality engineering activities for medical device and related products, including process validation, testing, inspection, statistical analysis, supplier qualification, design controls, risk management, and regulatory documentation. Investigates nonconformances, develops CAPA, supports 510(k) submissions and CE technical files, ensures compliance with domestic and international standards, and trains cross-functional teams. Requires at least four years of quality or engineering experience and up to 15% travel.
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Senior executive responsible for operations quality leadership at Medline Industries. The provided description contains limited role-specific responsibilities, but the position likely oversees quality strategy, operational performance, compliance, continuous improvement, and organizational execution across the company.
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Leads quality engineering activities for medical device products and processes, including process validation, testing, statistical process control, supplier qualification, CAPA and SCAR management, nonconformance investigations, and corrective actions. Maintains design control files, Device Master Records, product specifications, and CE technical files. Supports regulatory compliance, 510(k) submissions, product development, risk management, laboratory testing, employee training, and cross-functional quality improvements.
Other
Leads Quality Assurance strategy and compliance for assigned product divisions, ensuring adherence to FDA, EU MDR, cGMP, and other applicable requirements. Oversees quality functions, staffing, training, process changes, new product development, supplier qualification, and cross-functional communication. Manages and mentors QA personnel while supporting efficient product and service launches. Requires at least 7 years of QA experience and 5 years of people management. Travel is required up to 20%.
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