Clinical Quality Assurance Specialist – Fixed-Term

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🕒 Maio 22

⛷️ Utah – Remoto

⛷️ Utah – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Merit Medical Oncology

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1987

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $4.248.192 Venture Round - Cianna Medical em 2016-10

Healthcare • Consulting • Logistics

Merit Medical Oncology é uma divisão/especialidade da Merit Medical Systems focada em dispositivos e soluções procedimentais para intervenções oncológicas. É parte da Merit Medical Systems, uma fabricante global fundada em 1987 que projeta e comercializa dispositivos médicos descartáveis proprietários utilizados em procedimentos intervencionistas, diagnósticos e terapêuticos nas áreas de cardiologia, radiologia, oncologia, cuidados críticos e endoscopia. A Merit Medical Oncology apoia hospitais e médicos em todo o mundo com produtos (por exemplo, biópsia, emboloterapia, drenagem e outras ferramentas de intervenção relacionadas à oncologia), educação e treinamento de clínicos, documentação regulatória e de produtos, além de distribuição global e suporte ao cliente.

Descrição

• Ensures that company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility. • Consult with Merit staff regarding the use of products in a clinical setting by clinicians. Provides clinical input for new product design and development. • Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints. • Answers incoming customer calls to collect clinical information. • Provides clinical training to employees and customers on the complaint system requirements. • Establish relationships and builds confidence among lab staff, physicians, Sales Representatives, and other Merit customers. • Ensures clinical details involving customer complaints are documented. • Attends meetings to help determine which events/incidents require notification to regulatory authorities. • Creates and submits reportable adverse events to regulatory agencies. • May supervise the work of technicians or others who assist in related assignments. • Responsible for complaint Nonconformances (NC’s) and Corrective Preventive Actions (CAPA) and investigates, resolves issues and determines course of action. • Initiates and/or implements action to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices. • Identifies and records any product, process and quality system problems. • Provide clinical input on and approve investigation methods and experiments. • Provide clinical input from a complaint perspective on CRA, HSA and FMEA development. • Write documents to address complaints, investigations, or reports requiring clinical input. • Makes presentations at and/or attends local, regional, and national meetings requiring clinical expertise, knowledge, and experience. • Performs other duties and tasks as required.

🎯 Requisitos

• Education and/or business experience equivalent to a Bachelor's degree in a scientific discipline or related area. • A minimum of five years of hands-on medical experience, preferably with medical devices. • Excellent communication, interpersonal, and organizational skills, detail oriented, and the ability to work effectively as a team member. • A thorough understanding of customer service practices. • Ability to independently apply analytical and problem solving skills to understand and solve complex issues. • Knowledge of medical product/device use. • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

🏖️ Benefícios

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights • Medical/Dental & Other Insurances (eligible the first of month after 30 days) • Low Cost Onsite Medical Clinic • Two (2) Onsite Cafeterias • Employee Garden | Gardening Classes • 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays • 401K | Health Savings Account