Senior Quality Engineer

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🕒 Janeiro 22

🚗 Michigan – Remoto

🚗 Michigan – Remote

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Genesis Innovation Group

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🤝 B2B

🔧 Hardware

🔬 Ciência

B2B • Hardware • Science

A Genesis Innovation Group é uma empresa de desenvolvimento de dispositivos médicos baseada nos EUA que faz parceria com inventores e empreendedores para levar tecnologias médicas desde a concepção até a engenharia, aprovação regulatória, fabricação e comercialização. A empresa oferece serviços de ponta a ponta, incluindo desenvolvimento de protótipos, manufatura aditiva e de precisão, suporte regulatório ISO 13485 e 510(k)/PMA, estratégia clínica e de mercado, financiamento e planejamento empresarial, além de distribuição e treinamento para clínicos. Com equipes multidisciplinares experientes e relações na indústria, a Genesis orienta os clientes por caminhos técnicos, de qualidade e comerciais complexos para levar dispositivos ao mercado.

Descrição

• Identify, analyze, critique, and correct quality control processes and documented procedures • Interact with a variety of suppliers and the Genesis family of companies to ensure consistency, accuracy, and the implementation of best practices • Formulate or help formulate quality assurance policies and procedures • Review and provide input to design plans, user requirements, design inputs, test procedures, risk management file, and design outputs to understand the scope, requirements, and function of the systems • Ensure that products meet the organizations and customers’ quality and product integrity requirements • Support the product development team by providing analysis and expertise throughout the inspection process • Identify root causes of problems in the production process; recommend and/or implements corrective measures • Analyze data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects • Ensure manufacturing processes comply with federal, state, local, and industry standards and regulations • Perform risk analysis as part of the risk management team • Perform gap analyses on standards and regulations as new customers are brought onboard and as new or revised standards are released • Conduct training on quality assurance concepts and tools • Monitor, manage and handle complaints, feedback, and non-conforming products • Find, devise, handle, and enforce corrective and preventative actions • Communicate with engineering and productions within an organization and with customers and suppliers on quality-related issues • Work within the QMS team to ensure the overall quality of a manufactured product • Create, support, and oversee documentation • Develop quality control systems • Analyze quality assurance test results to ensure that the end product meets the exact needs of the user

🎯 Requisitos

• Bachelor of Science in Engineering or related degree required • Specific Medical quality design experience required • Minimum of 6 years of related experience in a regulated environment • Experience in the medical device industry preferred • Experience with Design Controls and Risk Management required • Experience with complaint and CAPA handling a plus • Geometric Dimensioning and Tolerancing experience a plus • Ability to work individually and on a team • Ability to solve quality issues with remote suppliers • High attention to detail

🏖️ Benefícios

• Competitive wages • Bonus program • Benefits • Strong team collaboration