SR. DESIGN QUALITY ENGINEER - MANUFACTURING, LIFE SCIENCES; REMOTE, USA

Por qué te necesitamos? If you want to discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.
We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly creative, diverse and passionate team members collaborating across the globe.
We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.
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 , ISO , Saint-Gobain global quality management procedures, and relevant regulatory and industry standards.
Leads the execution of quality owned design activities following the ISO , and ISO 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 standards, relevant regulatory requirements, and industry guidance, including.
Provides direction & support for design control activities per ISO 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 and ISO , 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 ¿Este trabajo es para ti? Bachelor's Degree within Biology, Microbiology, or other relevant scientific/engineering field; Required.
5+ years of experience - within Quality, within a regulated industry with a preferred emphasis in life sciences (i.
.
pharma, biopharma or medical device).
2+ years of experience - with Design/Controls experience; Required.
Strong knowledge of ISO and cGMP requirements and relevant industry standard practices; Required.
Knowledge of Quality Management Systems and Product/Process Life  Cycle Management within manufacturing; Required.
Capable of measuring product characteristics & reading/interpreting technical instructions, drawings & blueprints; Required.
Ability to Travel upwards of 15%; Required.
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