Complaint Handling Specialist

Company: Clearcorrect
Location: Round Rock
Posted on: June 2, 2021

Job Description:

Summary of position Supports and implements systems in the areas of post market surveillance, complaint handling, and customer feedback. Supports the development of and enforces internal systems and procedures to meet ISO standards, FDA quality system regulations, and other regulatory requirements. Essential functions and duties Receives customer complaints and performs root cause investigations using RCA tools/methodologies. Tracks and trends data and initiates CAPAs, where appropriate Receives customer returned product and performs investigation. Collects customer feedback and reports findings to management Works closely with multifunctional teams for all post market surveillance tasks. Able to prioritize workload to ensure maximum efficiency and customer Collects data and reports via Management Review Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area. Accurately records and reports of information as required. Follows employee policy within the company. Non-essential functions and duties Attends Quality and other meetings as required. Participates in additional training relevant to this position. Other duties may be assigned, directed or requested. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to ensure individuals with disabilities are able to perform the essential functions of the role. Technical writing skills desired. Ability to work with multidisciplinary teams to execute projects, investigations, and training. Demonstrated ability to plan and work to robust timelines Excellent understanding of quality principles and good documentation practices. Familiarity with US and International medical device regulations. Experience in investigation techniques and problem solving. Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts. Must have excellent written communication skills. Must have basic computer skills (Microsoft Office). Apply for This Job

Keywords: Clearcorrect, Round Rock , Complaint Handling Specialist, Other , Round Rock, Texas