Careers that Change Lives A Day in the Life Position Description Performs the coordination and/or preparation of internal and external audits and compliance in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities). Interprets government regulations as they apply to products, processes, practices and procedures. Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met. Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. Analyzes audit data and presents findings to management, supports Corrective Action Plans, and provides coaching to business partners. May assists in managing recalls and field actions. Develops and implements programs designed to increase employee awareness and knowledge of compliance policies Position Responsibilities Manages the facility internal audits program. Coordinates Divisional, Corporate, FDA, ISO, and compliance audits. Reviews complaint and failure investigations of our products for adequacy, completeness and compliance to regulations and internal procedures. Manages CAPA System activities to assure adherence to internal procedures and regulatory requirements. Prepares activity reports. Analyzes Quality System data sources to identify adverse trends and critical issues. Elevates appropriately to Management for action. Coordinates Management Review and Quality Review sessions in accordance with internal procedures. Issues meeting minutes and follows-up on status of activities. Participates in the development and preparation of project plans for quality system activities. Ensures compliance with company regulatory compliance programs/procedures. Maintains up to date information of new laws and regulations and keep management informed on any changes and their effect in operations. This includes the review of reports received from external sources such as: G.M.P. letter, FDA reports to implement corrective actions. Performs other related duties as assigned. Quality Responsibilities Reports any observed or informed process and/or product non-conformities to the Supervisor for action and resolution. Reports any complaint regarding a Medtronic product to the Supervisor. Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledge and maintain commitment with the EHS Policy. Participate in the development of EHS improvement projects. Participate actively in the EHS programs to achieve the objectives and targets defined for the area. Minimum Education Bachelor Degree Basic Qualifications Background Educational: Science, Engineering, Business Administration or related field Experience: o Senior or Level 3 5 Years with Diploma/ Degree or 3 Years with Advanced Diploma/ Degree Exposure to quality and manufacturing environment Skills Interpersonal Relations Quality and Results Oriented Computer Literate Fluency speaking and writing in English and Spanish Desired/ Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry Demonstrate skills and experience in the Qualification / Validation activities. Training and experience in quality tools such as; auditing, DOE, SPC, FMEA, Gage R & R, ISO/FDA standards and regulations. Knowledge of statistics, problem solving techniques and validation of equipment/processes Skills Problem Solving Teamwork Communications Continues Improvement Root Cause Analysis Technical Writing and Composition Auditing Working Conditions Mental Components: Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document. Physical Components: Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment. Environmental Work is performed in building's interior with normal temperature, good illumination, air condition, clean environment and minimum risk SDL2017
