Product Analysis Laboratory Coordinator

LivaNova•Houston, TX

51d•$25 - $35•Onsite

About The Position

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives. This position is responsible for supporting the product troubleshooting activities that require specialized technical product experience and knowledge. The incumbent is responsible for supporting the quality system in accordance with documented procedures, quality standards, and regulatory requirements. The incumbent is authorized to identify and report nonconformances in materials, components, products, processes, equipment, facilities, and other parts of the quality system; to initiate corrective action, where applicable; and to identify and initiate corrective action of nonconformances in documentation, design, equipment, facilities, and processes, and other activities covered by the quality system.

Requirements

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.

Nice To Haves

Prior experience working within a healthcare laboratory setting

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.