To perform this job successfully, an individual must be able to capably perform each of the following essential functions: 

Duties:

• Responsible for supporting the Design Control process and ensuring that Design History Files comply with Technopath Clinical Diagnostic (TCD) policies/procedures and applicable regulatory requirements.
• Act as the Quality representative on Design Control projects from project initiation through to product launch to ensure compliance to applicable procedures and standards.
• Manage and lead the change control process by liaising with impacted areas to ensure timely and compliant implementation and completion.
• Work in collaboration with R&D, Labelling, Operations, Validation, Business Development and Supply chain on design control and change control projects.
• Review and approve all process validation documentation inclusive of plans, protocols and reports ensuring compliance to applicable procedures and standards.
• Responsible for creation and maintenance of Risk Management Files for each product.
• Facilitate process and design failure mode and effects analysis meetings.
• Responsible for maintaining Design Control and R&D procedures to ensure compliance to regulatory or standard requirements.
• Perform Post Market Surveillance activities per the requirements of the applicable procedures and regulations.
• Liaise with external customers on change requests.
• Provide training and guidance to staff on the requirements of the design control and change control process in TCD.
• As required perform internal audits to ensure compliance of TCDs quality management system to the requirements of all applicable requirements.
• Perform other related duties as prescribed by the Global Design QA and Risk Manager and Director of Quality Assurance.