WORK BREAKDOWN STRUCTURE GOAL: Support the MTC manufacturing operations by continuous assessment of the indirect materials required to produce the final device, supplied by the supplier. Inspection and review of the materials to meet the required standard is the main goal of the work. The inspection process includes different testing, analyzing and resolve any issue related to the materials.
• This procedure is intended to capture material information throughout the life of the finished product.
• Finding every component detail, such as chemical information and structural formula, applicable material formulation information, specification of raw materials (including compounding ratios if relevant). manufacturer and supplier details.
• Will work on new process and template to release.
• Determining the surface area of the finished device to work with Microbiology team perform biocompatibility testing. Biocompatibility evaluation of components, materials and finished devices should be performed to all Healthcare finished product or component/material used in the manufacture of Healthcare products that have direct or indirect contact with the human body.
• Keep tracking of applicable vendor biocompatibility, chemical composition testing of raw materials.
• Collecting data regarding type of patient contact and duration of the contact for all catheters. This patient contact assessment will be done following ISO10993-1.
• Update material of concern table and consult with the R&D, Microbiology team members to determine if there are any regulatory implications of having any of these materials in the finished device.
• Will collaborate with Quality Management System (QMS) and Quality Documentation System to get approval of any supplier related issue.
• Will attend in classroom trainings and will complete online trainings to UpToDate with FDA regulations and standards and SOPs, Work instructions, Quality system regulatory requirements.
• As a part of Sourcing Continuity team I will be responsible for continuous improvement of supplier's processes and materials.
• Maintaining continuity of supply of components purchased from different suppliers and qualification of supplier changes within the supplier and Danvers manufacturing sites. Initiate Change Order (CO) for all supplier change activities.
• Will work on Corrective and Preventive action (CAPA) associated with any type of supplier changes.
• Determination if the required material or service from the suppliers are within scope or out of scope following purchasing controlled documents. Make sure component qualification will be done to remain align with requirements, regulation
Required Qualification & Experience:Bachelors degree required in Engineering, Chemistry or closely related field.
