FDA-Regulated Complaint & Quality Specialist

FUJIFILM Healthcare Americas Corporation; United States; On-site; USD 74,000 - 82,000; Full time

Benefits offered by this job

Medical benefits

Life insurance

401k

Paid time off

Bonus opportunity

Job summary

FUJIFILM Healthcare Americas Corporation is seeking a Complaint Handling professional to ensure full compliance with U.S. FDA medical device regulations and ISO 13485 standards.

You will evaluate customer complaints, document investigations, and coordinate with Regulatory Affairs, Quality Assurance, and other cross-functional teams to drive timely CAPAs and prevent recurrence. This role emphasizes strong leadership, clear communication, and collaborative teamwork to support regulatory compliance

Qualifications

• Three or more years of quality system support in a U.S. FDA regulated environment.
• Deep knowledge of U.S. FDA medical device regulations (21 CFR 820/803/806/807).
• Familiarity with ISO 13485/ISO 9001 and related medical device standards.

Responsibilities

• Evaluate and document customer complaints, perform trend analysis, and maintain records.
• Identify and escalate potential reportable events to Product Safety, Regulatory Affairs, and QA.
• Process customer complaints in the quality management system.
• Collaborate with Customer Service, Service, R&D, QA, RA and Sales to drive action.
• Support CAPAs, non-conformances, audits, and remediation activities.
• Assist with adverse event reporting and field actions.

Skills

Leadership

Communication

Collaboration

Teamwork

Education

Bachelor Degree

Job description

FUJIFILM Healthcare Americas Corporation is seeking a Complaint Handling professional to ensure full compliance with U.S. FDA medical device regulations and ISO 13485 standards.

You will evaluate customer complaints, document investigations, and coordinate with Regulatory Affairs, Quality Assurance, and other cross-functional teams to drive timely CAPAs and prevent recurrence. This role emphasizes strong leadership, clear communication, and collaborative teamwork to support regulatory compliance