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Complaint Analyst

Company: Aerotek
Location: Vista
Posted on: February 18, 2021

Job Description:

Description:A Solution provider that requires a very high degree of technical competence and communicative ability to receive, evaluate, investigate, and respond to Product complaints. Must be well versed in the QSR and ISO 13485:2016 requirements for Complaint handling. Corresponds with management regarding the results of inquiries and analysis of product complaints.Responsible for conducting complaint investigations with follow up and analysis.Uses discretion in escalating unusual product performance issues, collaborates with cross functional teams to help resolve customer complaints. Performs complete lifecycle product complaint documentation to support defensible compliance in the regulatory space. Ensure handling of Customer Complaints in accordance with applicable standards and regulations. Ensure optimization of the current Customer Complaint process including the implementation of a new Customer Complaint System.Lead cross-functionally to ensure adequate temporary & permanent countermeasures are put in place in a timely manner, and sustained, to address the appropriate customer complaints.Keep updated knowledge of standards, regulatory requirements related to complaint handling. Provide data, trending, and detailed analysis of Complaint data to support defensible compliance. Aid in the development and implementation of corrective and preventive actions to address complaint handling. Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate.Seek information and input, and challenge cross functional teams as appropriate. Evaluate product complaints for Medical Device Reporting (MDR). Work with the Regulatory group to prepare and submit MDR reports to Regulatory agencies. Identify problems and lead projects to improve processes, procedures, and/or practices; provide solutions including devising new approaches to Complaint handling. Participate in and drive projects in the RA/QA function. Support the organization during External Audits.Support the organization in Complaint training activities.Skills:complaint analysis, iso 13485, fda complianceTop Skills Details:Product complaints, FDA, ISO 13485,Additional Skills & Qualifications:Experience & Qualifications:Strong Cross departmental communication skills, someone who enjoys working cross functionally, helping to identify important department interfaces, and streamlining processes in a growing and rapidly changing environment.Strong understanding of Quality processes related to incidents and complaints and how that interfaces with FDA eMDR reporting requirements.Demonstrates excellent interpersonal skills with personnel at all levels and exhibits a high degree of initiative, enthusiasm, commitment, and motivation.Education:BS degree in Life Sciences or ASQ or other related certifications. Versed in the QSR, ISO 13485 and related quality Standards.Versed in 21 CFR Part 803Strong working knowledge of complaints management systemsExperience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Vista , Complaint Analyst, Professions , Vista, California

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