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Complaint Handling Specialist

Fujifilm

Twinsburg, OHRemoteJob$74–82K/yrTracked 4w agoSeen in employer's feed 5 days ago
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At a glance

Compensation
$74–82K/yr
Location
Twinsburg, OHRemote
Work Authorization
Not specified

Job overview

Fujifilm is hiring a Complaint Handling Specialist. The Complaint Handling Specialist provides support to FUJIFILM Healthcare Americas Corporation, ensuring full, ongoing compliance with U.S. FDA medical device regulatory requirements, ISO 13485 standards, and all other applicable laws, regulations, and standards while contributing to a dynamic, flexible environment that encourages innovation and collaboration.

Key focus areas include Evaluate all sources of incoming customer information, identify, investigate and document complaints, Identify all customer complaints, take appropriate action and maintain records, and Escalate potential reportable events to Product Safety Committee, Regulatory Affairs and Quality Assurance.

Successful candidates bring Three Plus Years Quality System Support Experience, Deep Knowledge Of U.S. FDA Medical Device Regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807), and Deep Knowledge Of International Medical Device Standards (ISO 13485, ISO 9001, ISO 14971, EU Medical Device Directive, Canada Medical Device Regulations). Important skills include U.S. FDA Medical Device Regulatory Requirements, ISO 13485 Standard Requirements, 21 CFR 820, 21 CFR 803, 21 CFR 806, and 21 CFR 807. Preferred (not required): Computer Skills, Multi-Tasking, and Proactive Thinking.

Skills & qualifications

RequiredNice to have

Skills

U.S. FDA Medical Device Regulatory RequirementsISO 13485 Standard Requirements21 CFR 82021 CFR 80321 CFR 80621 CFR 807ISO 9001ISO 14971EU Medical Device DirectiveCanada Medical Device RegulationsLeadershipCommunicationCollaborationTeam WorkInterpersonal SkillsComputer SkillsInternet Search SkillsMulti-TaskingMeet Business DeadlinesOrganizational SkillsProactive ThinkingPrioritize WorkComplaint HandlingTrend AnalysisQuality Management SystemCorrective and Preventive ActionCAPAsNon-ConformancesInternal/External AuditsRemediation ActivitiesAdverse Event ReportingField ActionsISO 13485U.S. FDA Medical Device RegulationsInternet SearchMulti-TaskEvaluate Customer InformationIdentify Customer ComplaintsInvestigate Customer ComplaintsDocument Customer ComplaintsPerform Trend AnalysisMaintain RecordsEscalate Reportable EventsProcess Customer Complaints in Quality Management SystemPerform Corrective and Preventive Action ActivitiesSupport Quality Management System ActivitiesSupport Regulatory Affairs ActivitiesComply With U.S. FDA Medical Device Regulatory RequirementsComply With ISO 13485 Standard RequirementsComply With Applicable Laws, Regulations, and StandardsEffectively Communicate With Staff MembersEffectively Communicate With Business PartnersThink ProactivelyTime ManagementFDA Medical Device RegulationsCAPA ActivitiesComplaint InvestigationComputer and Internet SearchCAPACustomer Complaint HandlingU.S. FDA 21 CFR 820U.S. FDA 21 CFR 803U.S. FDA 21 CFR 806U.S. FDA 21 CFR 807Computer and Internet Search SkillsRegulatory AffairsInterpersonalOrganizationalComputer

Qualifications

3+ Years Quality System Support Experience in U.S. FDA Regulated EnvironmentBachelor Degree

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
Paid Time Off
401(k) Match

Full job description

Position Overview

This position is intended to provide Complaint Handling support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Company Overview

At FUJIFILM Healthcare Americas Corporation, we’re on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics.

But we don’t stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly.

Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive.

Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Duties and 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 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 activities as needed.

  • Support other Quality Management System activities as they relate to Customer Complaints (CAPAs, Non-conformances, internal/external audits, remediation activities)

  • Support other Regulatory Affairs activities as they relate to Customer Complaints (adverse event reporting, field actions).

  • Attend all department and company-wide team meetings as needed.

  • Other duties as assigned.

  • Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.

Qualifications

Experience

  • Three (3) or more years of hands on experience performing Quality System supportactivities in a U.S. FDA regulated environment.

  • Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21CFR 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).

Educational Requirements

  • Bachelor Degree highly preferred.

Special Skills or Other Job Requirements:

  • 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.

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed

capabilities:

  • The ability to sit up 75-100% of applicable work time.

  • The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.

  • The ability to stand, talk, and hear for 75% of applicable work time.

  • The ability to lift and carry up to ten pounds up to 20% of applicable work time.

  • Close Vision: The ability to see clearly at twenty inches or less.

Travel

  • Occasional (up to 25%) travel may be required based on business need

Salary and Benefits:

  • $73,759.00 - $82,000.00 + 8% Bonus opportunity

  • Medical, Dental, Vision

  • Life Insurance

  • 401k

  • Paid Time Off

*#LI-Remote In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements.

For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected] or (330) 425-1313).

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Job Locations US-Remote

Posted Date 5 days ago (8/12/2026 12:41 PM)

Requisition ID 2026-38318

Category Regulatory/Compliance

Company (Portal Searching) FUJIFILM Healthcare Americas Corporation

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