Complaint Analyst Job Description
Complaint analyst
provides medical input into the Medical Device and Combination Products complaint process including Medical Device and Post Market Safety Reporting.
Complaint Analyst Duties & Responsibilities
To write an effective complaint analyst job description, begin by listing detailed duties, responsibilities and expectations. We have included complaint analyst job description templates that you can modify and use.
Sample responsibilities for this position include:
Using working knowledge and understanding of the US FDA regulations for medical devices regarding Medical Device Reports (MDRs), and complaint handling and reporting, the Quality Assurance Complaint Analyst ensure complaint investigations are adequate, accurate, detailed and timely
Successfully execute reporting and analytics
Prepares and analyzes monthly reports for assigned line of business and affiliates
Develops an understanding of 5/3 Banks business lines and systems
Review all Sales Practice and Non-Sales Practice complaints for Wealth Management received through the Intake Mailbox
Identify non-sales practice concerns and refer matters to the firm’s Account Services, Operations, for possible corrective action
You will perform complaint management and reporting activities that include device assessments and submissions, complaint coding, dispositions
Write, review, and file Medical Device Reports and potentially Vigilance Reports as required
Exhibit strong ability to collaborate and influence Business Partners (Internal Manufacturing sites, External Business Partners, Call Intake Centers, and Global Medical Safety
Analyze events reported from multiple inputs to determine complaint status and regulatory reportability
Complaint Analyst Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Complaint Analyst
List any licenses or certifications required by the position: ASQ, RAC
Education for Complaint Analyst
Typically a job would require a certain level of education.
Employers hiring for the complaint analyst job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Engineering, Education, Medical, Technical, Business, Nursing, Technology, Medical Technology, Pharmacy
Skills for Complaint Analyst
Desired skills for complaint analyst include:
Global regulatory requirements for pharmaceutical
Medical devices and combination products
FDA requirements for Quality Systems
Medical Device Reporting regulations
Pharmaceutical products
MS Office applications
Medical Devices is highly desired
Statistics/quality control desired
Global Servicing Network processes
Medical Devices
Desired experience for complaint analyst includes:
Handles and processes potentially contaminated complaint samples using appropriate PPE Independently scopes, retrieves, reviews, trends, analyzes and reports data using spreadsheets, graphs, and databases
Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations
Elevate issues to management as appropriate
Interacts with customers via telephone and written correspondence regarding post market issues
Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS)
CAPA, and MDR reporting experience required
Complaint Analyst Examples
1
Complaint Analyst Job Description
Job Description Example
Our company is hiring for a complaint analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for complaint analyst
- Evaluate adverse events and product quality complaints and conducts complaint investigation in accordance with Standard Operating Procedures using the Product Quality Management System
- Perform complaint case review, trend analysis, return sample evaluation, malfunction coding, as applicable, and investigation by manufacturing site and escalation, as appropriate
- Develop and deliver training presentations for complaint vigilance process and systems
- Prepare and present Complaint Vigilance data to QA Management and cross functional business partners
- Lead various projects and activities related to Complaint Vigilance process and system implementations and improvements
- Monitor Complaint Records in system to ensure standard process is being followed and complaints are closed as required
- Evaluate adverse events and product quality complaints and processes cases in accordance with Standard Operating Procedures using the Product Quality Management System
- Complaint documentation meets Good Documentation Practices
- Triage and evaluate non-serious and serious product quality complaints and processes product quality complaints in accordance with Standard Operating Procedures using the Product Quality Management System
- Utilizes an approved script to call members who have enrolled via UHC’s public web portal, to determine compliant application processes
Qualifications for complaint analyst
- Knowledge of Bio-Hazardous Materials and related safeguards and protocols
- Must have demonstrated ability to think strategically
- Demonstrated ability to manage multiple activities and tasks
- Regulatory and Quality Management knowledge and skills
- 5 years analytical experience working with large and disparate relational databases
- BA/BS in Engineering, Quality, or Science related – REQUIRED
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Complaint Analyst Job Description
Job Description Example
Our growing company is looking to fill the role of complaint analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for complaint analyst
- Review and evaluate Dispensing Medical Device complaint files for potential adverse events in concert with the MDR/Vigilance requirements to ensure timely reporting to FDA or other regulatory agencies
- Gather information to allow for the filing of appropriate medical device reports with various regulatory agencies
- Participate in and share complaint information with various cross-functional teams
- Performs inquiry and analysis of SAP and Dispensing device transactions to provide actionable data to Quality Management
- Conduct data collection, data mining, analysis, and reporting on ad hoc and recurring basis to monitor compliance and identify potential issues
- Communicate analytical results in both a written and presentation format to executive leadership
- Participate in continuous improvement efforts specific to complaint data and analytics
- Provide leadership to the Ultrasound Designated Complaint Unit (DCU) to ensure compliance with all post market activities including complaint processing, investigations and 803 reportability
- Ensures investigations are assigned, track investigation progress and ensure root cause determination
- Responsible for reporting post market surveillance metrics on a periodic basis
Qualifications for complaint analyst
- Measurement systems / test method knowledge and analysis
- Failure analysis and investigation
- Process mapping and value stream analysis
- Descriptive statistics
- Process capability analysis, and
- Experience with technologies supporting complaint handling (PQMS or similar system) is required
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Complaint Analyst Job Description
Job Description Example
Our company is searching for experienced candidates for the position of complaint analyst. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for complaint analyst
- Represents the Designated Complaint Unit during internal audits and external audits from regulatory authorities
- Continually strives to improve compliance and efficiency within the team
- Demonstrates leadership and mentoring capabilities
- Exhibits a strong work ethic and pays attention to detail
- Possesses critical thinking and problem solving abilities
- Performs best in a fast paced environment
- Product complaint documentation, investigation, and review of all non-medical complaint content
- Perform assigned complaints investigations, including but not limited to Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, ) and investigation reports
- Prepare weekly and monthly metrics for Quality Management Reviews and Operational Reviews such as trend charts, Pareto Analysis, , as required under the guidance of the area manager
- Quality Problem Resolution by means of Root Cause/Problem Solving Analysis
Qualifications for complaint analyst
- Experience with tools and techniques supporting qualitative risk analysis preferred
- Supports Quality Audits internally and externally with regard to customer complaints
- Communicate with complainant as needed to follow up on and resolve complaint
- Knowledge of the Merrill Edge business
- Usage of WMW and other Merrill Edge systems
- Special investigations, provider relations, customer service or audit experience is preferred
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Complaint Analyst Job Description
Job Description Example
Our innovative and growing company is looking for a complaint analyst. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for complaint analyst
- Complaint determination
- Reportability assessments
- Evaluates, investigates, and resolves complaints
- Completes initial assessment of reportability and escalates to manager to determine action, when necessary
- Verify CF correctness of CF/Complaint Type and update if necessary
- Open additional / separate CFs when multiple issues/ multiple patient events occur
- Performs follow up activities to obtain additional information
- Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools
- Participates and/or leads special projects
- Process and analyze product complaints according to Policies and Standard Operating Procedures
Qualifications for complaint analyst
- 1 - 2 years related work experience in Quality Complaints
- Prior experience performing product evaluation in a regulated industry is preferred
- Knowledge in record keeping, computer software, laboratory procedures used for evaluation of samples, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred
- Prior experience with the products and their usage is highly desirable
- Must demonstrate effective written and verbal communication, including technical writing skills
- Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred
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Complaint Analyst Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of complaint analyst. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for complaint analyst
- Partner with customers JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Brand Protection, Central Complaint Vigilance, to gain knowledge of products and processes
- Review complaint investigations for accuracy and completeness
- Ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making
- Compile product and site-specific complaint trending data and complaint closure metrics as requested Support internal and external audits and inspections
- Participate within and/or facilitate special projects
- Partner with customers to continuously identify, assess, and improve complaint handling processes and documentation
- Review product quality complaint and investigation documentation to ensure quality and accuracy of information
- 4+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related or highly regulated industry
- Relevant knowledge on root cause investigations production, lab environment
- Strong interdependent partnering skills, interpersonal communication, influencing skills
Qualifications for complaint analyst
- This position will be based out of Fort Washington, PA and may require up to 10% travel depending on business needs.Quality Assurance
- Strong knowledge of U.S. FDA regulations of medical device/IVD adverse event and field action assessment, health hazard evaluation, product risk safety analyses, MDR/recall reporting, IVD/Medical Device labeling requirements and 21 CFR 820 and process requirements
- Demonstration of good documentation practices
- Experience in a regulated industry preferred
- Demonstrates knowledge of analysis techniques and tools
- Knowledge of SQL database or equivalent data warehouse experience to assist in collection and analyzing data