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The Sr. Design Quality Engineer is responsible for supporting quality engineering activities to support the new product development life cycle, from concept to commercialization.

Will serve as the key quality resource on the cross functional new product development teams for ensuring compliance to ISO 9001, ISO 13485, Saint-Gobain global quality management procedures, and relevant regulatory and industry standards.

Leads the execution of quality owned design activities following the ISO 9001, and ISO 13485 Quality Management system standards and applicable regulations.

Key Functions:

New Product Development:

Supports and assures the quality oversight for the new product introduction for single use assemblies in compliance with corporate quality policies, procedures, ISO 9001/13485 standards, relevant regulatory requirements, and industry guidance, including:

Provides direction & support for design control activities per ISO 13485 for new product introduction. Executes the quality owned deliverables as identified as part of the Design processes. Reviews, assesses and provides quality approval for the New Product Development documentation to ensure compliance throughout product development cycle. ensures the product design meets customer expectations, ISO standards, regulatory requirements, and corporate requirements. Shows focus toward continuous improvement. Contributes to the risk management for new products and provides assurances that control measures are translated into appropriate (critical) requirements (Design outputs). Troubleshoots & directs the resolution of quality issues by fostering effective cross-functional partnerships. Investigates & liaises with operation & design teams on design related product complaints to resolve difficult quality problems on products. Directs and facilitates investigations and the corresponding preventive and corrective actions that result from quality inquiries, abnormal results or other quality performance indicators for new products. Analyzes development and product data for trends related to product safety, quality and performance. Trains, coaches and increases awareness while promoting a culture focused on patient safety and quality.

Supplier Qualification:

Supports qualification of new suppliers being introduced through the new product introduction process following the requirements of ISO 9001 and ISO 13485, relevant industry standards, regulations, and corporate requirements. Participates and provides input to purchasing control processes, procedures, and systems in compliance with applicable regulations for new supplier or new components being introduced. Verifies the regulatory and product compliance of the new supplier and/or new components in accordance with defined new product requirements. Liaises with purchasing team to support supplier related duties and responsibilities. Supports remediation of regulatory and product compliance for existing suppliers and components as part of corporate initiatives