Medline Industries, LP · 2 days ago
Sr Quality Assurance Auditor - Chicagoland area
Illinois, United States
Full-time
Onsite
Mid, Senior Level
$96K/yr - $145K/yr
4+ years expMedline Industries, LP is a global healthcare company that focuses on providing high-quality medical products. The Sr Quality Assurance Auditor will audit suppliers against FDA regulations and ISO standards, lead supplier regulatory projects, and conduct internal audits to ensure compliance across Medline's diverse product portfolio.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals
As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements
Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers
Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers
Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements
Conduct adequate CAPA follow-up for supplier and internal audits
Write audit reports and communicate results to upper management
Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally
Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies
Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers
Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs
Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services
Assist in integration of new acquisitions into Medline’s quality system. Perform due diligence audits for potential acquisitions
Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers. Assist in managing the rotational QA program
Qualification
Required
Education - Bachelor's degree in microbiology, chemistry, engineering or related field
Work Experience - At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing
Experience with FDA regulations (21 CFR 820, 21 CFR 210/211)
Experience with ISO 13485
Experience applying knowledge of process validation, method validation and sterilization processes
Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills
Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions
Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary
Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines
Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally)
Preferred
Experience with USP 61/62 for Microbial Testing of Non-Steriles
Experience applying knowledge of process validation, method validation and sterilization processes
Experience in CAPA (Corrective and Preventive Actions) management
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline Industries, LP
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline Industries, LP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
2025-12-26
TheStreet.com
2025-12-20
2025-12-19
Company data provided by crunchbase