Principal Investigator FSE

Medline Industries, LP • Northfield, IL

98d • $132,600 - $199,160

About The Position

Responsible for leading assessment, investigation, and corrective actions associated with Global Field Safety Events: Recalls, Corrections, and Removals activities associated with Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Principle authority in high risk and high financial impact Global Field Safety Events investigation and corrective actions. Lead, create, and manage communication related to Field Safety Events with Global regulatory agencies. Support Global Quality Systems related activities associated with Field Safety Events. Provide expertise, counsel and guidance to Quality leadership, product SME.

Requirements

• 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.

Nice To Haves

• 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.

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 associated 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.

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees