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Product Complaint Associate

Company: Advantage Technical Resourcing
Location: Santa Clara
Posted on: August 1, 2020

Job Description:

Product Complaint Associate 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 Preferred Skills and Job Experience 1 years of experience in medical device field required, 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. 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. Education Associates Degree, Bachelor's Degree or Master's Degree Location Santa Clara, CA At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales. Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire. Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor.

Keywords: Advantage Technical Resourcing, Santa Clara , Product Complaint Associate, Other , Santa Clara, California

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