Medline · 6 hours ago
Principal Specialist Quality Process
Northfield, Illinois
Full-time
Hybrid
Senior Level, Lead/Staff
$101K/yr - $152K/yr
7+ years expMedline Industries is a leading healthcare company focused on quality and compliance in the medical device and pharmaceutical sectors. The Principal Specialist Quality Process will lead strategic project implementation related to system management, ensuring compliance with regulatory standards and driving improvements in quality systems across the organization.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Review, advise on, and approve CAPAs and other major investigations as independent reviewer and QMS advisor
Provide feedback and drive adherence to investigation content requirements and expectations
Lead personnel and activities to establish and maintain quality systems including trending, analysis and reporting of quality metrics
Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures
Identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business
Develop, assess, and define key quality metrics/indicators to track performance and compliance
Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities
Investigate the applications of electronic documentation systems. Purchase, implement, and coordinate use of the systems and training personnel. Collaborate with cross-functional teams to deploy quality processes and systems
Consult and provide guidance to business partners
Execute responsibilities as CRB team member. Lead CRB team in systems analysis and effectiveness measures
Train and coach personnel to deliver optimal results based on the department’s goals
Oversee critical Quality systems projects
Develop strategy and manage the relationship with notified bodies for quality systems evaluation. Manage and coordinate Notified body/Registrar Quality Systems registration strategy
Host and coordinate Notified body/ Registrar Quality Systems audits. Support in customer and regulatory audits
Qualification
Required
Bachelor's degree in a technical or scientific discipline
At least 7 years of experience with medical device or pharma Quality Management Systems
Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO)
Proficiency in Microsoft Suite, MS Visio, MS Project, Minitab
Position requires travel up to 10% of the time for business purposes (within state and out of state)
Preferred
Experience with Medical Device and Pharma, multiple product types, and regulatory jurisdictions
Experience with quality systems development and implementation
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions
Experience in the Medical Device and Pharmaceutical industry
Experience hosting FDA/ISO GMP inspections
Experience with SAP
Experience with ETQ Reliance
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline 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
2026-01-13
2026-01-07
2025-12-26
Company data provided by crunchbase