Complaint Analyst III

Integrated Resources, Inc

Irvine, California

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Analysis Skills, Biology, Change Control, Chemistry, Clinical Information, Code Reviews, Communication Skills, Computer Skills, Computer Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Detail Oriented, Documentation, Employee Retention, English Language, Establish Priorities, FDA (Food and Drug Administration), Information/Data Security (InfoSec), Medical Equipment, Microsoft Windows Operating System, Multitasking, Nursing, Presentation/Verbal Skills, Process Improvement, Project/Program Management, Quality Engineering, Quality Management, Regulations, Regulatory Reports, Reporting Dashboards, Root Cause Analysis, Talent Management, Technical Writing, Time Management, Writing Skills

LOCATION

Irvine, California

POSTED

1 day ago

Complaint Analyst IIIIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.Job DescriptionDuties:The Complaints Coding Specialist will review and analyze assigned customer complaints; and proper investigate the complaint and contact the customer if necessary.This individual will evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.The Complaints Coding Specialist will ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.The Complaints Coding Specialist will develop, establish, prepare and distribute dashboards and reports to assure complaints are processed and coded in a timely manner.This individual will develop a thorough understanding of the complaint database.Additionally, The Complaints Coding Specialist will develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required.The Complaints Coding Specialist will escalate critical issues for proper disposition as necessary.Authors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance FilesReviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as RequiredIndependently Completes Medium Complexity Complaint Investigations within Required Timelines (e.g. "Out of the Box" Failure Investigations) Initiates Company Issue Escalation Process as RequiredInvestigates and Documents Complaint Trend AnalysesCoordinates Initiation of Company CAPA Process as RequiredMakes Significant Contributions to Improvement InitiativesContributes to Document Change OrdersMaintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management andProcessing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy LawsPerforms other duties assigned as neededQualificationsRequired Minimum Education:Bachelor's Degree or Equivalent - A degree in Science, Engineering, Nursing, Biology, Chemistry or related technical field4-6 years related experience years related experienceExperience in medical device or other FDA regulated industry.Required Skills:Must possess the basic understanding of engineering fundamentals.Advanced critical thinking and investigation skills are required.Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Candidate must be able to effectively prioritize and manage multiple activities and responsibilities.Ability to understand and follow complex written procedures is required.Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.Ability to function in a team environment and deliver on team objectives is required. Ability to influence and drive change is preferred. Prefer project management and/or process mapping experience.Communication Skills: Strong written and verbal communication skills are required. Must be highly proficient in reading, writing, and speaking the English language.Technical writing is a routine part of this position. Strong attention to detail is required.Required Computer Skills:Familiarity with computers and Windows-based PC applications.Ability to learn and manipulate complex computer system applications is required.Ability to type at least 50 words per minute (WPM) is required. Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) is required.Prefer experience with Siebel Complaint Management System.Additional InformationThanks!! With Regards, Sasha Sharma Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Direct: 732-662-7964 | (W) 732-549-2030 x 219Inc. 5000 – 2007-2015 (9 Years in a row)

Complaint Analyst III

Integrated Resources, Inc

Irvine, California

About the Company

Integrated Resources, Inc

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