Saint-Gobain · 12 hours ago

Sr. Design Quality Engineer - Manufacturing, Life Sciences; Remote, USA

Solon, OH

Full-time

Remote

Mid, Senior Level

$88K/yr - $136K/yr

5+ years exp

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Responsibilities

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.

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ISO 9001ISO 13485Quality Management SystemsDesign ControlsCGMP RequirementsRisk ManagementNew Product DevelopmentSupplier QualificationBiology DegreeMicrobiology DegreeLife Sciences ExperienceTechnical InstructionsBlueprint ReadingCoaching

Required

Bachelor's Degree within Biology, Microbiology, or other relevant scientific/engineering field

5+ years of experience within Quality, within a regulated industry with a preferred emphasis in life sciences (i.e. pharma, biopharma or medical device)

2+ years of experience with Design/Controls experience

Strong knowledge of ISO and cGMP requirements and relevant industry standard practices

Knowledge of Quality Management Systems and Product/Process Life Cycle Management within manufacturing

Capable of measuring product characteristics & reading/interpreting technical instructions, drawings & blueprints

Ability to Travel upwards of 15%