Clinical Quality Assurance Specialist – Fixed-Term

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🕒 vor 2 Monaten

⛷️ Utah – Remote

⛷️ Utah – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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Merit Medical Oncology

WebsiteLinkedInAlle Stellen

5001 - 10000 Mitarbeiter

Gegründet 1987

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

💰 €4.248.192 Venture Round - Cianna Medical im 2016-10

Healthcare • Consulting • Logistics

Merit Medical Oncology ist eine Abteilung/Spezialisierung der Merit Medical Systems, die sich auf Geräte und prozedurale Lösungen für onkologische Interventionen konzentriert. Sie ist Teil von Merit Medical Systems, einem weltweit tätigen Hersteller, der 1987 gegründet wurde und der proprietäre Einweg-Medizinprodukte entwirft und vermarktet, die bei interventionellen, diagnostischen und therapeutischen Verfahren in der Kardiologie, Radiologie, Onkologie, Intensivmedizin und Endoskopie eingesetzt werden. Merit Medical Oncology unterstützt Kliniken und Ärzte weltweit mit Produkten (z. B. Biopsie, Embolotherapie, Drainage und andere onkologiebezogene interventionelle Werkzeuge), Ärzteschulung und -training, regulatorischen und Produktdokumentationen sowie globalem Vertrieb und Kundensupport.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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