Design Quality Engineer II

🕒 Julho 27

🌪️ Kansas – Remoto

🌪️ Kansas – Remote

💵 $65.269 - $169.742 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Agiliti

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1939

🏥 Saúde

📦 Logística

🤝 B2B

Healthcare • Logistics • B2B

A Agiliti é uma empresa de serviços de saúde que gerencia, mantém e oferece suporte a equipamentos médicos e tecnologia clínica para provedores de saúde. A empresa oferece operações de campo e atendimento ao cliente, engenharia clínica, manufatura e engenharia, sistemas de tecnologia e informação, e serviços de cadeia de suprimentos/logística projetados para garantir que os equipamentos críticos estejam disponíveis e prontos para uso por pacientes. A Agiliti se posiciona como um parceiro B2B para hospitais e organizações de saúde, enfatizando uma cultura orientada por missões, serviço comunitário e diversidade e inclusão.

Descrição

• Utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers. • Act as a team member in supporting quality decisions and practices. • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Apply statistical methodologies for assessment and to resolve potential product and quality system issues. • Develop and maintain or support the development of testing plans, models and methods for raw materials, materials in process, and finished goods. • Collaborate with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers. • Coordinate planning and execution of first article inspections and approvals. • Coordinate planning, execution, and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams. • Lead activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans. • Plan, develop, and oversee execution of Design verification and validation protocols. • Lead advanced product quality planning activities and assist in preparing new product designs for certification testing. • Participate in projects and cross-functional teams. May lead mid-scale projects.

🎯 Requisitos

• Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required. • 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements. • ISO13485 and FDA 21CFR820 highly desired. • Working knowledge and experience with metrology labs preferred and GD&T. • Experience with medical device ISO14971 Risk Management. • Previous working experience in a Design Quality Assurance role for medical device equipment is required. • Working knowledge of IEC 60601-1 Safety standards preferred, but not required. • Use of statistical analysis software for SPC & CPk Analysis • Tooling and fixturing development and qualification (FAI and Gage R&R) • Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.

🏖️ Benefícios

• health insurance options for Medical, Dental & Vision plans • Short- and Long-Term Disability plans • Flexible Spending Accounts • Health Savings Accounts • Life Insurance Options • Paid Time Off • 401K Saving Plan with employer match • Employee Discounts • Tuition Reimbursement • Daily Pay program • Employee Assistance Program • wellness programs