Compliance Engineer

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🕒 Outubro 24, 2025

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Spectrum Plastics Group, A DuPont Business

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🤝 B2B

🔧 Hardware

💊 Farmacêutico

B2B • Hardware • Pharmaceuticals

Spectrum Plastics Group, um negócio da DuPont, é um fabricante global e parceiro de serviço completo que projeta, desenvolve e fabrica componentes médicos especiais, subconjuntos e dispositivos acabados. A empresa fornece tubos médicos extrudados, tecnologias de cateter, balões médicos, moldagem por injeção de precisão (incluindo implantáveis e biorreabsorvíveis), processamento a laser e embalagens estéreis flexíveis, apoiando o desenvolvimento de produtos através de protótipos, suporte regulatório/qualidade e produção escalável para clientes de dispositivos médicos e entrega de medicamentos. A Spectrum atende a uma variedade de mercados clínicos e industriais e foi adquirida pela DuPont, expandindo suas capacidades em embalagens e componentes médicos.

Descrição

• Provide support to Spectrum sites and its customers through leadership in materials documentation for certifications • Establish and maintain a centralized material regulatory statements repository across the Spectrum enterprise • Develop and communicate clear technical and administrative guidance to project teams • Maintain compliance statuses of Spectrum business materials with existing, new or amended regulations • Manage and maintain materials-related sites compliance requirements and reporting obligations • Guide project teams to ensure that design systems fulfil customer expectations and site materials-related regulatory compliance • Streamline and manage regulatory-related customer inquiries response process • Serve as a focal point to and coordinate site responses for the PS&R organization • Collaborate with PS&R to develop responses for any corporate-driven risk and regulatory compliance management • Review existing documents (procedures, work instructions, etc.) for accuracy, robustness, and compliance

🎯 Requisitos

• Engineering Degree • 4 years of experience in Quality and/or Compliance Engineering in a manufacturing environment • Supplier Quality Management experience is a plus • Experience with quality systems regulations and standards (ISO 13485, ISO 9001, FDA 21 CFR 820, AS9200, FSSC 22000) • Knowledge of applicable material compliance regulations and standards (EUMDR, REACH regulation (EU)1907/2006, CLP, RoHS, Cal Prop.65, SCIP, WEEE, etc.) • Certification agency (UL, or similar) experience is a plus • Experience using statistical analysis tools • Experience in testing, defect data and data analysis utilizing advanced methods • Excellent computer skills (such as Excel, Word, Access, PowerPoint, SharePoint, etc.) • SAP experience is a plus • Demonstrated ability to lead projects, process execution, and critical issue closure across technical disciplines and organization functions • Demonstrated ability to prioritize tasks and objectives • Demonstrated ability to identify and drive continuous improvements efforts • Strong communication/presentation skills, tailored to audience (oral, written, and/or presentation) including listening

🏖️ Benefícios

• Health insurance • Flexible work arrangements