Plans, conducts, and documents results of discussions with individuals in such Interviewing: a manner as to achieve assessment objectives; ability to determine accuracy of information from interviewees and potential indicators of further follow-up action. Skilled in obtaining relevant, reliable, and useful information from individuals at all levels in the audited organization. Provides constructive feedback to assessment team members. Ability to identify Teamwork: needs and methods for performance improvement; assists with handling performance issues. Provides environment to maximize Auditor proficiency. Recognizes the potential and actual sources of personnel conflict from Conflict Resolution: assessment program stakeholders. Achieves results through diplomatic handling of disagreements and potential conflict; works effectively and cooperates with other individuals and departments to resolve conflicts. Plans, organizes, directs, monitors, and evaluates the work of others assigned to Supervision: assessment projects. Creates and concise reports and presentations that are based on Writing Literacy: objective evidence. Uses correct spelling, grammar, and punctuation to produce logical and accurate written documentation and correspondence. Communicates ideas, information, and messages, which may contain technical material, in a logical, organized, and coherent manner. Monitors progress against objectives and completes duties in timely and Time Management: effective manner. maintains accurate and objective records of facts and observations Records Management: made. Observant and respectful to different cultures. Cultural Sensitivity: Ability to work independently and adjust to unforeseen circumstances with Autonomy: minimal assistance. Technical Competencies Knowledge of the medical device regulatory requirements of the Regulatory requirements: recognizing Regulatory Authority(s) to enable an assessment of the applicability and compliance with such laws, regulations, and standards. Including knowledge of the principles and applications of medical device quality management system requirements, risk management system requirements, etc. Knowledge of medical devices and the related manufacturing activities, Medical devices: including: their intended use types of medical devices including their complexities, technologies, and risk classifications
Interviewing: Plans, conducts, and documents results of discussions with individuals in such a manner as to achieve assessment objectives; ability to determine accuracy of information from interviewees and potential indicators of further follow-up action. Skilled in obtaining relevant, reliable, and useful information from individuals at all levels in the audited organization. Teamwork: Provides constructive feedback to assessment team members. Ability to identify needs and methods for performance improvement; assists with handling performance issues. Provides environment to maximize Auditor proficiency. Conflict Resolution: Recognizes the potential and actual sources of personnel conflict from assessment program stakeholders. Achieves results through diplomatic handling of disagreements and potential conflict; works effectively and cooperates with other individuals and departments to resolve conflicts. Supervision: Plans, organizes, directs, monitors, and evaluates the work of others assigned to assessment projects. Writing Literacy: Creates and concise reports and presentations that are based on objective evidence. Uses correct spelling, grammar, and punctuation to produce logical and accurate written documentation and correspondence. Communicates ideas, information, and messages, which may contain technical material, in a logical, organized, and coherent manner. Time Management: Monitors progress against objectives and completes duties in timely and effective manner. Records Management: maintains accurate and objective records of facts and observations made. Cultural Sensitivity: Observant and respectful to different cultures. Autonomy: Ability to work independently and adjust to unforeseen circumstances with minimal assistance. Technical Competencies Regulatory requirements: Knowledge of the medical device regulatory requirements of the recognizing Regulatory Authority(s) to enable an assessment of the applicability and compliance with such laws, regulations, and standards. Including knowledge of the principles and applications of medical device quality management system requirements, risk management system requirements, etc. Medical devices: Knowledge of medical devices and the related manufacturing activities, including: their intended use types of medical devices including their complexities, technologies, and risk classifications
imdrf-tech-131209-competence-and-training-requirements-140901.docx