Medical Device Complaint Investigator

• 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:

• Bachelor’s 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 (SOP’s) 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.