**Quality Systems Lead**When you show proactivity and ambition, we'll harness it through a variety of opportunities and challenges in the diverse areas of our business - all with a strong and meaningful purpose. Where do you want to go? What do you want to do? How do you want to make a difference? The choice is yours, and we'll help you get there. **Be better together. Be Bayer**.**YOUR TASKS AND RESPONSIBILITIES**Deviations:- Report, monitor and control CAPA/Deviations System metrics at the management level and development of trend analysis.- Execute verification of effectiveness plans.- Ensure adequate control of QMRB Cage and material disposition.Internal/External Audits & Compliance:- Lead internal audit program and execute audits to ensure compliance with regulations and international standards. Support supplier audits when required.- Report, monitor and control metrics related to CAPA/Deviations System and investigations derived from audits at the management level and development of trend analysis.- Support external audits for regulatory bodies to meet local and international standards and Bayer Corporate Audits. Follow up the adequate investigation process and CAPA implementation plans.- Promote the GxPs in the company.- Promote coordinated teamwork to achieve Data Integrity Standards.Complaints:- Responsible to oversee the analysis of complaints received from costumers, including the revision of history of the device and its tendency.- Ensure complaints are processed within the established timeframes.- Oversee the correct execution of cases by Gatekeeper and RQU.Document Control Areas:- Responsible to oversee Change Management Systems: Document Control,Training, External Documents/CMS Regulations & Master Control Administrator to provide quality systems development to meet Quality System requirements.Environmental Monitoring:- Manage Environmental Monitoring System and microbiological control.- Plan and monitor budget.- In charge of executing investigations of environmental control and coordinate the implementation of action plans in a timely manner.- Responsible for developing validations of the environmental controlled room and/or process impacting the environmental control of clean rooms and/or equipment or auxiliary systems including CMSO approval process.- Coordinate and/or execute the environmental monitoring.Calibrations:- Responsible to oversee calibrations area and ensure equipment is properly calibrated, and calibration is performed on time.Reports:- Responsible to lead the compilation, analysis and reporting of Quality Metrics (including but not limited to Management Review, KPIs, Quality Board and SQMR) to detect signals and anticipate potential non-conformities and to maintain key performance indicators as per quality objectives.- Perform improvements as identified.People:- Responsible to lead direct reports such as Quality Systems Coordinator, Quality Engineer for Complaints and Quality Engineer Gatekeeper.Others:- Responsible for safeguarding all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their field of work, in order to avoid incidents that affect the productivity and distribution of our products that may cause economic impact for the company or a breach with our customers, suppliers, shareholders and / or other key audiences.- Promote continuous improvement by identifying problems and development of projects to determinate the fundamental causes of the problems and definition and implementation of action plans.- Act as approver in documents assigned in Master Control and some other quality related documents in paper based as required.- Other duties can be assigned to the employee once the corresponding training is completed.- Act as deputy for Management Representative.**WHO YOU ARE**- Bachelor´s Degree in Engineering (Industrial, Chemical, Mechanical, Electronics, Electrical), Microbiologist, Pharmacist or any other related career.- At least 5 years of experience in the Quality Areas of a medical device company (mandatory).- At least 3 years of experience supervising personnel.- Advanced English level in reading, writing and speaking.- Knowledge in Project Transfers and Validations.- Strong knowledge in Statistical Techniques (DOE, Acceptance Sampling, SPC).- Knowledge in Process/Product and Test Methods, Project Management, Failure Analysis.- GxP and Data Integrity Requirements.- ISO-13485, ISO-14644 & FDA auditing requirements.- Extensive and strong problem solving, root-cause analysis and technical/engineering skills to lead and influence change are considered assets.- High-level computer knowledge (Excel, Word, E-mail, Change Control, Power Point, SAP, Project, Visio, Minitab).- CQE, Green or black belt (Desirable).- Internal Quality Auditor.- Strong leadership, conflict resolution, and negotiation skills required. Capable of lead
