Medical Device Complaint Investigator

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Essential Functions: Performs routine testing on products returned from the field due to customer complaint; utilizes a variety of lab equipment to perform testing. Coordinates, evaluates, investigates, tracks, and performs complaint testing and investigations through established complaint handling processes and procedures. Reviews relevant records (e.g. batch records, quality control data, deviations/CAPAs) and performs authenticity assessment of all received complaint samples. Serves as a subject matter expert (SME) for applicable procedures and work instructions related to investigation process; collaborates with subject matter experts (SMEs) in other departments to adequately evaluate and investigate complaints. Summarizes and records all test data when applicable; maintains proper documentation of the evaluation and investigation results within the assigned complaint file(s). Determines the need for additional investigations; forwards product complaint records and/or complaint sample(s) to other departments or outside sources for further investigation, when required. Requests supplementary information from the reporter and/or related parties when additional information may aid in determining the root cause of the product complaint. Determines the need for corrective action(s). Reviews risk for each complaint; determines when new risks are identified. Performs product complaint sample retrieval actions per local procedures as needed. Performs and/or verifies results of visual and/or functional analysis of returned complaint samples per local procedures. Applies cGMP and cGLP principles in all phases of the product complaint investigation (e.g., data documentation). Builds and maintains working relationships other departments. Contributes to post-launch product complaint monitoring activities. Ensures accuracy and appropriateness of investigation report content. Performs other related duties and projects as business needs require at direction of management.Education and Experience: Bacheloru2019s degree in Science, Engineering, or equivalent relevant experience preferred. Minimum two (2) years of experience in a GMP relevant environment. Experience working with FDA regulated products in medical device/IVD industry preferred. Experience conducting complaint investigations and root cause analysis. Demonstrated knowledge of ISO 13485 and FDA QSR Part 820 / 803 requirements preferred. Experience following Standard Operating Procedures (SOPu2019s) preferred. Experience with NCRs, FMEAs, CAPAs, or Product Risk Assessments is preferred.Knowledge and Abilities:Proficient knowledge of general office procedures.Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook). Proficient knowledge of Good Documentation Practices (GDP) relating to complaint handling.Proficient knowledge of medical terms and human anatomy.Advanced knowledge and interpretation of domestic and international complaint handling and reporting requirements required. Demonstrated knowledge of statistical data analysis tools and techniques.Demonstrated knowledge of good laboratory practices, including handling of chemicals and biohazardous material.Demonstrated problem-solving, critical thinking, and investigate skills.Demonstrated prioritization and time management skills.Demonstrated reliability, dependability, and flexibility in work habits.Demonstrated attention to detail and accuracy.Ability to prioritize and organize project tasks and goals effectively.Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.Ability to read technical diagrams, graphs, and instructions.Pay Range: $27-$37/hr

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