Complaint Handling Specialist

This position provides Complaint Handling support to FUJIFILM Healthcare Americas Corporation, ensuring full compliance with U.S. FDA medical device regulatory requirements, ISO 13485 standards, and all other applicable laws and regulations.

About the role

At FUJIFILM Healthcare Americas Corporation, we innovate for a healthier world by delivering cutting-edge healthcare solutions in diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. Our Non-Destructive Testing (NDT) team also advances radiography solutions to support transportation infrastructure, aerospace, and oil and gas safety. Headquartered in Lexington, Massachusetts, we are part of a global organization with over 70,000 employees across healthcare, electronics, business innovation, and imaging, guided by our Group Purpose of “giving our world more smiles.”

Responsibilities

• 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 all potential reportable events to the Product Safety Committee, Regulatory Affairs, and Quality Assurance.
• Process all customer complaints in the quality management system.
• Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs, and Sales to facilitate required action.
• Perform Corrective and Preventive Action (CAPA) activities as needed.
• Support other Quality Management System activities related to customer complaints (CAPAs, non-conformances, internal/external audits, remediation activities).
• Support Regulatory Affairs activities related to customer complaints (adverse event reporting, field actions).
• Attend all department and company-wide team meetings as needed.
• Comply with all applicable U.S. FDA medical device regulatory requirements, ISO 13485 standards, and other relevant laws and regulations.

Qualifications

• Three 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’s degree highly preferred.

Skills and other requirements

• Excellent leadership, communication, collaboration, teamwork, and interpersonal skills.
• Superb ability to communicate effectively with staff and business partners at all organizational levels (internal and external).
• Excellent computer and internet search skills.
• Strong ability to multitask and meet business deadlines.
• Excellent organizational skills with the ability to think proactively and prioritize work.
• Occasional (up to 25%) travel may be required based on business need.

Physical requirements

• Ability to sit up to 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 up to 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.

Pay

$73,759.00 – $82,000.00 + 8% bonus opportunity.

Benefits

• Medical, dental, and vision insurance.
• Life insurance.
• 401(k).
• Paid time off.