Product Complaint Associate

Company: cPrime, Inc.
Location: Santa Clara
Posted on: November 22, 2020

Job Description:

An Alten Company, Cprime is a global consulting firm helping transforming businesses get in sync. Cprime is the partner of choice for Fortune 100 companies looking to achieve value and agility. We help visionary business leaders compose solutions, execute implementations, and exceed against business goals. With our key partnership recognitions, including Atlassian Platinum, AWS Advanced, and SAFe Gold partner, our industry-leading software and services work in synergy to deliver transformations. As the largest Atlassian Platinum Solution Partner, Cprime is committed to helping our clients to best utilize their Atlassian products and tools, from assessment and design, to configuration, and all the way to enterprise scaling. Our team is made up of Atlassian and Agile certified experts who have combined technical and functional expertise and who can bridge both process and tools to build technology solutions. We are committed to growing and developing our talented people through learning opportunities, growth opportunities, and diverse projects Cprime is looking for a strong Product Compliant Associate to investigates customer complaints, makes an initial reporting decision, and ensures completeness and consistency of complaint and related documentation. Roles and Responsibilities Investigating complaints daily Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training as required. Follow and comply with company procedures and processes relating to complaint intake, assessment and reporting. Process, record and close assigned complaint handling activities in a timely manner. Perform the preliminary classification of complaints. Perform Failure Analysis investigation review and escalate complaints that require additional review. File Malfunction MDR Reports as identified Escalate Adverse Event or Incident reports as identified Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file. Approve final complaint file for closure after all applicable actions are completed. Manage complaint workload to required backlog goals. Escalate complaints to the Regulatory Post Market Surveillance Manager or Supervisor when new failure modes are encountered Escalate complaints to the Post Market Investigation (PMI) group as required Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements. Interface with internal and external sources to gather additional information required for complaint investigation, including retrieval of RMA Attend new hire training and continuous Regulatory Compliance training as required Participate in process improvement activities to continuously improve process effectiveness Execute on projects as required Perform other duties as directed Education Associates Degree, Bachelor's Degree or Master's Degree Experience 1+ years of experience in medical device field, with experience or exposure in the following areas Knowledge and basic understanding with Medical Device Complaint files and quality record documentation Knowledge and basic understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.) General technical and or clinical medical device knowledge General understanding of Regulatory Reporting requirements for Medical Devices and complaint system and process requirements for Regulatory Post Market Surveillance. General understanding of quality record requirements and how they apply to complaint files and regulatory reports. Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary. Skills Demonstrate strong written and verbal communication skills General computer skills (Excel, Word, PowerPoint, database) Efficient independent worker with ability to focus Attention to detail Demonstrate cross functional communication skills in email and in person Organizational and analytical skills Ability to handle and manage workload independently Prioritize numerous activities in a rapid paced environment Contribute to team oriented tasks Analytical skills Interpersonal and decision-making skills. Detail oriented and strong administrative skills including time management. Who is a Cprimer? We are dreamers and believers. We are the creatives and thinkers. Cprimers deliver! PLAYFUL - We're not the stodgy types of yesteryear. We're professional...and playful. STRUCTURED - We're structured in our thinking...But aren't afraid to shake things up. INSIGHTFUL - We act deliberately...and react dynamically. We're constantly on the move to find what's best for any situation. We keep our skills sharp and knowledge sharper by learning new technologies and training according to the most recent standards.

Keywords: cPrime, Inc., Santa Clara , Product Complaint Associate, Other , Santa Clara, California