Product Designer

• Perform the role of the Quality representative in Design and Development Projects.
• Responsible for Risk Management file creation and maintenance for products.
• Provide Quality Assurance support to assay and software verification and validation activities.
• Perform the review and approval of Assay Verification and Validation Protocols and Reports.
• Performs the review and approval of Software Verification and Validation Protocols and Reports.
• Performs review of Design Changes to identify the impact to products developed under design controls.
• Performs risk assessments for Design Changes.
• Ensure project plans adequately address design, verification, validation and compliance requirements and standards.
• Work with functional departments to ensure tasks are executed compliantly. Ensure resolution of protocol variances are performed ensuring compliance and issues are addressed and resolved.
• Management and documentation of Design Control activities
• Management and maintenance of the product Risk Management File according to ISO 14971:2019
• Support Quality System development and improvement to comply to ISO 13485 and FDA 21CFR820 and other applicable regulations.
• Support post launch design changes and product updates as required.
• Provides Quality Assurance expertise, guidance, coaching for New Product Development and single site PMA PAI Inspections.
• Follow all functions and responsibilities associated to this position that are described in UDx documents.

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