Product Analysis Laboratory Coordinator

LivaNova is a global medtech company committed to changing lives through innovative healthcare solutions. The Product Analysis Laboratory Coordinator will support product troubleshooting activities, ensuring compliance with quality standards and regulatory requirements while managing product returns and documentation.

Responsibilities

• Performs accurate receipt and proper disposition of all field return products. Resolves disparities between received product and associated documentation
• Coordinates notification of departments who will perform various functions related to the ultimate destination of product (other than Product analysis)
• Initiates financial accountability through SAP (and with support of Customer Support department) prior to final disposition of all field return product
• Documents “As-Received” condition of all explanted product, including digital image capture and downloading of internal memory from generators. (Decon)
• Performs Decontamination of all explanted devices and other support items which require cleaning prior to disposition to technical analysts. (Decon)
• Oversees scheduled disposal of biohazardous waste with outside contractor. (Decon)
• Processes assemblies and products from all in-house “Requests for Analysis” on an ‘as-needed’ basis and distributes final PA results to in-house requestor
• Supports the development and improvement of product analysis methods and procedures, for processes related to both existing and new product lines
• Performs other duties as may be required by management
• Coordinates final disposal of analyzed product following completion of retention period and after consultation with legal department
• Completes Product Analysis inventory listing for use by accounting department so they can reconcile financial product accountability
• Supports complaint investigations and the resulting preventive and/or corrective actions associated with the quality management system
• Supports the formal investigation of field reports, returns, and complaints as initiated through the CAPA system
• Assists in the implementation of the corporation’s quality goals and objectives
• Effectively communicates with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations

Skills

• 1-2 years of prior laboratory coordination experience required
• Exposure to MRP systems such as SAP
• Experience using electronic, measurement, and electronic image capture equipment
• Excellent written and verbal communications skills
• Proficient in MS Office
• Prior experience working within a healthcare laboratory setting

Benefits

• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules

Company Overview