Medline Industries, LP · 3 months ago
Principal Investigator FSE
United States
Full-time
Remote
Lead/Staff
$133K/yr - $199K/yr
10+ years expMedline Industries, LP is a leading organization in the medical field, and they are seeking a Principal Investigator FSE to lead the assessment and investigation of Global Field Safety Events. The role involves managing communication with regulatory agencies, supporting quality systems activities, and providing expertise to ensure compliance and improve quality processes.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Lead personnel and activities to investigate, correct, and prevent quality Field Safety Events (FSE) and potential Field Safety Events (pFSE) including root cause investigation, design, manufacturing and quality systems improvements
Develop, maintain, and improve process and procedures for in-depth investigations related to FSE and pFSE
Analyze highly technical and complex manufacturing, design, process, and user data to determine the root cause, scope, depth and of critical (high risk and high financial impact) Global Field failure events FSE and pFSE
Author and manage investigation/corrective action communication with regulatory authorities and applicable notified bodies for Field Safety Events. Act as SME Host during regulatory inspections and Notified body/ Registrar Quality Systems audits associated with the review of Field Safety Events
Collaborate with cross-functional teams, SMEs and business partners to compile strategic plans for the investigation, containment, and align correction efforts with effective divisional strategies relative to quality Field Safety Events
Oversee critical quality Field Safety Event - CAPAs and projects
Identify, lead and drive opportunities to improve quality systems and develop long-term strategies to prevent the reoccurrence of Field Safety Events globally on the product as well as similar products/processes
Review and determine the application of various global product jurisdictions to ensure compliance relative to Field Safety Events regulations
Oversee the improvement/corrective/preventive activities to DMRs, DHF/Tech Files, Master Batch Records, Validations, and change control to ensure risk based enhancement and maintenance of robust controls and documentation associate with Field Safety Events
Develop, assess, and define key quality metrics/indicators to track performance, effectiveness, and compliance assoicated with Field Safety Events
Ensure risk management strategies are appropriate, incorporated, and updated relative to Field Safety Events to meet regulatory expectations and mitigate future risks
Train and coach personnel to deliver optimal results based on the department’s goals
This is a high-level individual contributor role
Management responsibilities limited to leading day-to-day activities and outcomes of a group of employees
May be involved in hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies
Qualification
Required
Bachelor's degree in a technical or scientific discipline
At least 10 years of experience with Medical Device - Pharma Quality Management Systems, manufacturing, design, validation, supplier controls, clinical/patient risk assessments, and Field Safety Events regulations
At least 5 years of experience with high-risk, high complexity, high financial, critical failure investigation/CAPA activities
Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO)
Proficiency in Microsoft Suite
Position requires travel up to 20% of the time for business purposes (global)
Preferred
Experience with Medical Device and Pharma, multiple product types, and regulatory jurisdictions
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions
Experience with SAP
Experience with Contract Manufacturing
Experience with ETQ Reliance
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
2026-01-07
2025-12-26
TheStreet.com
2025-12-20
Company data provided by crunchbase