Complaint Handling Specialist

Emploi pas sur LinkedIn

🕒 il y a 20 jours

🇺🇸 États-Unis – Télétravail

💵 $73 759 - $82 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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FUJIFILM Corporation

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1934

🏭 Fabrication

🏥 Santé

Manufacturing • Healthcare • Electronics

La FUJIFILM Corporation est une entreprise mondiale fondée en 1934, opérant dans divers domaines, y compris la santé, l'électronique et l'imagerie. En tant que société de santé intégrale, FUJIFILM développe un large éventail d'activités dans la prévention, le diagnostic et le traitement. De plus, l'entreprise met l'accent sur la durabilité environnementale grâce à une efficacité industrielle améliorée, tout en capturant et préservant les souvenirs par le biais du film et de la photographie, enrichissant les vies émotionnelles et les connexions humaines.

Description

• Evaluate all sources of incoming customer information, identify, investigate and document customer complaints • Perform trend analysis and maintain all records • Identify all Customer Complaints, take appropriate action and maintain all records • Escalate potential reportable events to the Product Safety Committee, Regulatory Affairs and Quality Assurance • Process all Customer Complaints in the quality management system • Collaborate with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action • Perform Corrective and Preventive Action activities as needed • Support Quality Management System activities related to Customer Complaints, including CAPAs, non-conformances, internal/external audits and remediation activities • Support Regulatory Affairs activities related to Customer Complaints, including adverse event reporting and field actions • Attend department and company-wide team meetings as needed • Perform other duties as assigned • Support ongoing compliance with applicable U.S. FDA, ISO 13485 and other laws, regulations and standards

🎯 Exigences

• Three (3) or more years of hands on experience performing Quality System support activities in a U.S. FDA regulated environment • Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) • Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations) • Bachelor Degree highly preferred • Excellent leadership, communication, collaboration, team work and interpersonal skills • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external) • Excellent computer and internet search skills • Strong ability to multi-task and to meet business deadlines • Excellent organizational skills with an ability to think proactively and prioritize work • Ability to sit up 75-100% of applicable work time • Ability to use hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time • Ability to stand, talk, and hear for 75% of applicable work time • Ability to lift and carry up to ten pounds up to 20% of applicable work time • Close Vision: ability to see clearly at twenty inches or less • Occasional (up to 25%) travel may be required based on business need • Must comply with applicable U.S. FDA medical device regulatory requirements, ISO 13485 requirements, and other applicable laws, regulations and standards

🏖️ Avantages

• 8% Bonus opportunity • Medical, Dental, Vision • Life Insurance • 401k • Paid Time Off • Flexible environment • Reasonable accommodation in the application and selection process