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Medical Device Complaints Jobs (NOW HIRING)

Eisai

Mgr., Product Complaints (Hybrid)

Raleigh, NC · Hybrid

$104K - $137K/yr

This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR ...

SPECTRAFORCE

Data Entry Associate

Collegeville, PA · On-site

$15.75 - $20.50/hr

Product and medical device complaints Complaints that require expedited processing due to potential compliance issues. Responsible for recording and processing quality complaint information received ...

Spectra force

Data Entry Associate

Collegeville, PA · On-site

$15.75 - $20.50/hr

Qualifications Essential Functions: • Triage all incoming reports to immediately identify the following: • Product and medical device complaints • Complaints that require expedited processing ...

Masimo

Clinical Complaint Specialist

Irvine, CA · On-site

$80K - $100K/yr

Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements. * Perform clinical assessments of complaint ...

Masimo

Clinical Complaint Specialist

Irvine, CA · On-site

$80K - $100K/yr

Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements. * Perform clinical assessments of complaint ...

ConsignMed Inc.

Be Seen First

Clinical Specialist Medical Device

Odessa, TX · On-site

$100 - $150/day

Report customer inquiries, complaints, and service requests within 24 hours of being notified ... medical device or Operating Room experience, preferred * Gyn/Surg related experience, preferred

Terumo Corporation

Complaints Engineer II

Elkton, MD · On-site

$69K - $90K/yr

TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device ... The Complaints Engineer II is responsible for analyses, evaluation and product investigation of ...

Terumo Corporation

Complaints Engineer II

Elkton, MD · On-site

$69K - $90K/yr

TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device ... The Complaints Engineer II is responsible for analyses, evaluation and product investigation of ...

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Medical Device Complaints information

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$36

$70

How much do medical device complaints jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for medical device complaints in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What are medical device complaints?

Medical device complaints are reports or communications from users, patients, or healthcare professionals regarding potential problems, malfunctions, or adverse events associated with a medical device. These complaints may include issues such as device failure, product malfunction, labeling errors, or user injuries. Handling these complaints is crucial for ensuring patient safety and regulatory compliance, as manufacturers are required to investigate and report certain complaints to regulatory bodies like the FDA. Proper complaint management helps improve device quality and can lead to product improvements or recalls if necessary.

What are some common challenges faced in a medical device complaints role and how can they be managed?

Professionals in Medical Device Complaints often encounter challenges such as managing high volumes of complaint data, ensuring timely investigations, and maintaining compliance with strict regulatory requirements. To address these, strong organizational skills and attention to detail are essential, as is the ability to effectively communicate with cross-functional teams such as quality assurance, engineering, and regulatory affairs. Staying updated on evolving regulations and using complaint management software can also help streamline processes and ensure accurate reporting.

What are the key skills and qualifications needed to thrive as a medical device complaints specialist, and why are they important?

To thrive as a Medical Device Complaints Specialist, you need a solid understanding of regulatory requirements (such as FDA and ISO standards), strong analytical abilities, and a background in life sciences or engineering. Familiarity with complaint management systems, quality management software, and relevant certifications like Six Sigma or CAPA process training are typically required. Attention to detail, effective communication, and problem-solving skills are crucial for investigating issues and collaborating with cross-functional teams. These skills ensure accurate complaint handling, regulatory compliance, and continuous product quality improvement.

What is the difference between Medical Device Complaints vs Medical Device Quality Assurance Specialist?

AspectMedical Device ComplaintsMedical Device Quality Assurance Specialist
Primary FocusHandling and investigating complaints related to medical devicesEnsuring overall quality and compliance of medical devices during manufacturing
Required CredentialsTypically requires knowledge of regulations and complaint handling proceduresRequires quality management system knowledge, certifications like ISO 13485
Work EnvironmentCustomer service, complaint investigation teams, regulatory complianceManufacturing facilities, quality assurance departments
Industry UsageUsed by medical device companies to address post-market issuesUsed to maintain product quality and compliance throughout production

Medical Device Complaints focus on managing and investigating issues reported by users post-market, while Medical Device Quality Assurance Specialists oversee the quality systems and compliance during manufacturing. Both roles are essential in ensuring safe, effective medical devices but differ in their primary responsibilities and work environments.

More about Medical Device Complaints jobs

What states have the most Medical Device Complaints jobs?

States with the most job openings for Medical Device Complaints jobs include:

What job categories do people searching Medical Device Complaints jobs look for?

The top searched job categories for Medical Device Complaints jobs are:

Medical Device Complaints jobs near you
Infographic showing various Medical Device Complaints job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Medical Device Complaints Analyst

The Fountain Group

Alameda, CA • On-site

$54 - $59/hr

Other

Posted 3 days ago

New

Job description

100% ONSITE ALAMEDA CA

PAY: $54-$59/hr

MUST BE LOCAL TO THE ALAMEDA CA LOCATION


REQUIRED:

  • BS in Biomedical Engineering preferred
  • Medical device complaint handling
  • Quality data analysis and trending investigations
  • Complaint handling and complaint trend analysis
  • CAPA support and root cause investigation methodologies
  • Quality systems within FDA-regulated environments
  • Data analysis and reporting using Excel and related analytics tools
  • Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams
  • JMP
  • Advanced Microsoft Excel
  • SQL querying and data analysis
  • Power BI
  • Basic to intermediate Python programming
  • Quality and complaint management databases
  • Dashboard development and data visualization

Preferred Certifications

  • ASQ Certified Quality Engineer (CQE)


Job Description:

Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment. This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives. The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Key Responsibilities

Perform complaint tracking and trending activities using quality databases and analytical tools.

Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.

Support root cause investigations and CAPA activities.

Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.

Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.

Document investigative findings and support regulatory compliance requirements.

Assist with continuous improvement initiatives related to complaint handling and quality trending processes.

Present findings, recommendations, and data-driven insights to stakeholders.

Ideal Candidate Profile

The ideal candidate will have:

Experience working in a medical device or other highly regulated environment.

Strong analytical and problem-solving capabilities.

Experience analyzing complaint and quality data.

Exposure to CAPA processes and root cause investigations.

Ability to communicate technical findings clearly to cross-functional stakeholders.

Proficiency with data analytics and reporting tools.


Apply