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Complaint Assistant Jobs (NOW HIRING)

Support CAPA initiation and documentation related to complaint trends and investigation outcomes. * Assist with root cause analysis and corrective/preventive action documentation. * Support ...

Complaint Analyst

Columbia, SC ยท On-site

$37K - $60K/yr

With an unrivaled complaint processing portal, an award-winning communications staff and a unit ... Customer Service Support - Assist with general inquiries from consumers and businesses by phone or ...

Support internal audits, regulatory inspections, and quality system assessments related to complaint handling processes. * Assist with the development, maintenance, and continuous improvement of ...

$80K - $100K/yr

Support internal audits, regulatory inspections, and quality system assessments related to complaint handling processes. * Assist with the development, maintenance, and continuous improvement of ...

Clinical Complaint Specialist

Irvine, CA ยท On-site

$80K - $100K/yr

Support internal audits, regulatory inspections, and quality system assessments related to complaint handling processes. * Assist with the development, maintenance, and continuous improvement of ...

Clinical Complaint Specialist

Irvine, CA ยท On-site

$80K - $100K/yr

Support internal audits, regulatory inspections, and quality system assessments related to complaint handling processes. * Assist with the development, maintenance, and continuous improvement of ...

Perform initial complaint sample intake including logging samples, completing associated sample logs, and tracking sample retention. * Assist with other tasks in support of complaint investigations ...

Perform initial complaint sample intake including logging samples, completing associated sample logs, and tracking sample retention. * Assist with other tasks in support of complaint investigations ...

Perform initial complaint sample intake including logging samples, completing associated sample logs, and tracking sample retention. * Assist with other tasks in support of complaint investigations ...

Perform initial complaint sample intake including logging samples, completing associated sample logs, and tracking sample retention. * Assist with other tasks in support of complaint investigations ...

Identify complaint trends, recurring root causes, and control gaps; recommend process improvements to reduce future escalations. * Assist in developing escalation workflows, training materials, and ...

Identify complaint trends, recurring root causes, and control gaps; recommend process improvements to reduce future escalations. * Assist in developing escalation workflows, training materials, and ...

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Infographic showing various Complaint Assistant job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 76% Full Time, 21% Part Time, 1% Temporary, and 1% Contract. Highlights an 98% Physical, 1% Hybrid, and 1% Remote job distribution.

Complaint Handling Specialist

Madison, WI โ€ข On-site

Medasource
Health Care and Social Assistanceย โ€ขย 201 - 500 employees

Other

Posted 8 days ago


Job description

Our Client is seeking a Complaint Handling Specialist to join their Quality team in Madison, WI. This individual will be responsible for managing the complaint lifecycle for marketed medical device products, including complaint intake, investigation coordination, regulatory reporting documentation, and closure.

This role will have a strong focus on complaint investigations, MDR/vigilance reporting, CAPA support, audit nonconformities, and regulatory compliance. The ideal candidate will have handsโ€‘on medical device complaint handling experience and be comfortable partnering with crossโ€‘functional teams to ensure complaints are thoroughly investigated and completed within required regulatory timelines.

Key Responsibilities
  • Own the complaint lifecycle from initial intake through closure.
  • Determine whether reported events meet the definition of a complaint, assign complaint numbers, and maintain the Complaint Log.
  • Lead complaint investigations with cross-functional support and ensure appropriate product evaluations are completed.
  • Coordinate supplier evaluations or device repairs when necessary as part of complaint investigations.
  • Perform MDR/vigilance reportability determinations using applicable jurisdictional decision trees, including FDA, EU MDR, and Health Canada requirements.
  • Support maintenance of the FDA ESG account and submission of eMDRs, FDA Form 3500A, and supplemental reports within applicable regulatory timelines.
  • Document risk assessments and CAPA/SCAR assessments for complaints.
  • Communicate with complainants when appropriate and maintain complete documentation of correspondence.
  • Support CAPA initiation and documentation related to complaint trends and investigation outcomes.
  • Assist with root cause analysis and corrective/preventive action documentation.
  • Support investigations and corrective action documentation related to internal and external audit nonconformities.
  • Assist with coordination of the Complaint Review Board (CRB) and preparation of complaint metrics for Management Review.
Required Qualifications
  • Bachelor's degree preferred; equivalent professional experience will be considered.
  • 2+ years of medical device complaint handling experience.
  • Experience managing or supporting complaint investigations within a regulated medical device environment.
  • Strong documentation, organization, and attention to detail.
  • Ability to manage multiple investigations and regulatory timelines simultaneously.
  • Proficiency with Microsoft Office or similar business applications.
Preferred Qualifications
  • Experience working with electronic Quality Management Systems (eQMS).
  • Experience with ComplianceQuest is a plus.
  • Familiarity with MDR and vigilance reporting requirements.
  • Familiarity with CAPA processes and internal/external audit nonconformity investigations.
  • Familiarity with medical and clinical terminology related to interventional oncology.

This is an onsite position in Madison, Wisconsin, working within an office and light manufacturing/laboratory environment. The position may require extended periods of sitting or standing, regular computer use, and occasional lifting of up to 25 lbs.

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