Esteban Murillo Email & Phone Number

Maintaining the global complaint management quality systemManaging the planning and execution of special projects related to global complaint managementProviding business process oversight of the global complaint management technology solutionProviding complaint data management supportProviding operational support in the management and execution of quality system CAPAs and Non-conformances

Support the global complaint management quality system.o Coordinating and providing SME input for the development and maintenance of global complaint management processes and procedures within the appropriate document and change management framework.o Executing document and procedural change plans on behalf of the complaint management organization.o Developing and maintaining internal and external quality agreements related to complaint management activities across various S+N sites and third-party suppliers.o Managing supplier control activities related to the global complaint management system.o Leading preparation for internal and external quality system audits/inspections including coordination of backroom support to ensure fulfillment of auditor requests.o Providing front-room support for internal and external audits.o Providing subject matter expertise regarding regulations and complaint management process requirements to internal stakeholders.Lead project management support and key SME inputs for the planning and execution of special projects related to global complaint management.o Leading planning and execution of new product and/or company integrations.o Leading planning and execution of projects related to changes in global complaint and AE reporting regulations, including changes in processes / procedures / technology solutions.o Managing OPEX and continuous improvement project planning and execution.Provide operational support in the management and execution of quality system CAPAs, Nonconformances, and Audit Responseso Coordinating CAPA review meetings to ensure CAPA activities are tracked and appropriately managed.o Providing SME support to CAPA owners to ensure clear and consistent implementation of effective corrective and preventive actions.o Acting as QA Approver.o Acting as CAPAs, Nonconformances, and Audit Responses owner.

Alajuela, Costa Rica

o Managing a team of 8-10 Regulatory Compliance Analysts in Orthopaedics, Robotics and Wounds franchises.o Allocating team activities, preparing and monitoring daily or weekly team productivity reports and running ad hoc reports or preparing data reports.o Communicating with internal and external customers, including patients, healthcare professionals, concerning product issues and adverse events.o Tracking open and in-process complaints and related tasks and following up internally and externally as needed to completion.o Assuring education and training on proper methods of customer communication, complaint recording, complaint handling procedures, database, and any other training as needed.o Improving the complaint handling process through standardization of working practices. o Drafting policies, procedures, work instructions, and training materials to ensure proper compliance with regulations and standards.o Representing the department in different forums, both internally and externally.o Serving as host or SME for the process in internal audits or external inspections.

Training Development and Deliveryo Preparing or collecting information and materials to be used in conducting and/or facilitating training, meetings or seminars. This includes training plans, training guides / presentations, participant manuals, videos, slides and other materials.o Determining development needs through surveys, interviews, or other sources; reviews and analyzes special requests for training courses and professional development.o Scheduling and coordinating training classes, workshops, seminars, conferences or meetings.o Conducting classroom or one-to-one types of training using adult education and training principles. o Evaluating results and making changes or adjustments as needed.o Performing the review of the employees under trainingTraining Managemento Maintaining LMS Administrator qualification. o Maintaining the requirements for the Global Complaints Training Program.o Developing, establishing and maintaining compliant quality system processes and procedures in support of training delivery.o Maintaining complete and up-to-date electronic and paper course records in compliance with standards set by global policy & procedure.o Collaborating with various functions to evaluate and prepare role-based curricula and deploy Learning Plans in the LMS.o Reviewing training process feedback and implements corrective actions to address improvement opportunities found.Department Supporto Supporting Global Complaints projects and objectives as it relates to process and training development.o Facilitating resolution of quality and operational issues in a timely manner.o Coordinating communication with internal cross-functional teams when developing training initiatives.o Providing leadership and guidance to trainees to advance Smith+Nephew’s quality culture. o Providing subject matter expert (SME) feedback to management as complaint process experts. o Performing complaint handling tasks when needed.

Costa Rica

o Supporting the complaint handling process by acting as liaison amongst internal and external customers, including patients, healthcare professionals, sales representatives, and National Competent Authorities (NCAs) or Notified Bodies (NB), in relation to product issues, product information, patient requests and complaints.o Evaluating complaints to determine whether an adverse event report is necessary in accordance with 21 C.F.R. §803 (US), MEDDEV 2.12-1 (EU) M.D.R. 59-61.1 (CA) and any other worldwide regulatory requirements.o Prepararing, generating and submitting incident reports (MDR, MDVR) to the National Competent Authorities, whenever required, in an accurate and timely manner.o Creating and owning different reports that enable the team to stay in compliance with regulations and to achieve SLAs.o Proposing and implementing projects, using the Lean - Six Sigma approach, to improve the process.

Costa Rica

o Supporting the complaint handling process by acting as liaison amongst internal and external customers, including patients, healthcare professionals, sales representatives, and National Competent Authorities (NCAs) or Notified Bodies (NB), in relation to product issues, product information, patient requests and complaints.o Evaluating complaints to determine whether an adverse event report is necessary in accordance with 21 C.F.R. §803 (US), MEDDEV 2.12-1 (EU) M.D.R. 59-61.1 (CA) and any other worldwide regulatory requirements.o Prepararing, generating and submitting incident reports (MDR, MDVR) to the National Competent Authorities, whenever required, in an accurate and timely manner.o Creating and owning different reports that enable the team to stay in compliance with regulations and to achieve SLAs.o Proposing and implementing projects, using the Lean - Six Sigma approach, to improve the process.

Costa Rica

o Supporting the complaint handling process by acting as liaison amongst internal and external customers, including patients, healthcare professionals, sales representatives, and National Competent Authorities (NCAs) or Notified Bodies (NB), in relation to product issues, product information, patient requests and complaints.o Evaluating complaints to determine whether an adverse event report is necessary in accordance with 21 C.F.R. §803 (US), MEDDEV 2.12-1 (EU) M.D.R. 59-61.1 (CA) and any other worldwide regulatory requirements.o Prepararing, generating and submitting incident reports (MDR, MDVR) to the National Competent Authorities, whenever required, in an accurate and timely manner.o Creating and owning different reports that enable the team to stay in compliance with regulations and to achieve SLAs.o Proposing and implementing projects, using the Lean - Six Sigma approach, to improve the process.

Monterrey, México

Answering specific, chemistry-related questions for university-level students through Chegg's virtual platform.

Alajuela, Costa Rica

Tutoring university-level students for courses such as Mathematics I & II, Economics, Calculus I & II, General Chemistry I & II, Analytical Chemistry, and Organic Chemistry.

Monterrey, México

Drafting the theoretical framework for a new forensic method to analyze suicide-related cases.Developing a method to analyze neurotransmitters within complex biological samples.Managing instrumental equipment: high-performance liquid chromatography and tandem mass spectrometry.