Complaint Handling Specialist

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $73.8k - $82k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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FUJIFILM Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1934

🏭 Manufacturing

🏥 Healthcare

Manufacturing • Healthcare • Electronics

FUJIFILM Corporation is a global company established in 1934, operating in diverse fields including healthcare, electronics, and imaging. As a total healthcare company, FUJIFILM develops a wide range of businesses in prevention, diagnosis, and treatment. Additionally, the company focuses on environmental sustainability through improved industrial efficiency, while also capturing and preserving memories through film and photography, enriching emotional lives and human connections.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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