Manager Market Quality Colombia America Caldas
Advanced Sterilization Products
America, Caldas, co
hace 4 días
source : Ecadoo

At Fortive we believe in you We believe in your potential your ability to learn grow and contribute in meaningful ways We believe in the power of great people working together to innovate and solve problems no one could solve alone We build enduring partnerships with our customers and take on their challenges and opportunities as our own Your Impact The role of Manager Market Quality will promote correct standards of quality within the respective region by influencing and managing all quality related activities This role will work closely with the Sr Manager Market Quality to develop and implement Quality strategy and provide strategic leadership to the designated region The individual will interact with and provide oversight to local operating companies to ensure adherence to the ASP quality management system and local in country regulations Here s where you ll demonstrate your competencies Implements and oversees the ASP Quality Management System and its integrated programs within Canada such as quality systems training internal audits nonconformances corrective and preventive action records management field actions supplier quality management procurement servicing distribution and post market surveillance Assures compliance with applicable regulations such as but not limited to CMDCAS CMDR FDA 21 CFR 820 ISO 13485 etc Maintains sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics May serve as in country Quality representative aligned with local regulations or laws Participates and hosts internal and external audits May serve as liaison between local health authority and the business Maintains a comprehensive audit readiness program to ensure internal and external quality compliance Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs Establish local and regional relationships with regulatory affairs commercial and logistics team Maintains quality oversight of local distribution and warehouse management process assessment qualification monitoring Maintains quality oversight of any local required establishment licenses or QMS certifications Maintains local supplier vendor selection qualification and audits Maintains process for kitting repack relabeling activities if any Maintains quality records and adherence to records retention policies and procedures Maintains quality oversight of field service processes procedures Maintains quality training program with respect to quality system elements Establish corrective and preventive actions to mitigate potential or actual noncompliance risks Assesses product quality issues and escalates to upper management through established processes Ensures timely post market surveillance vigilance Field Actions and Product Complaints management Ensures timely and consistent escalation of events Responsible for communicating business related issues or opportunities to next management level Participates and hosts internal and external audits Promotes a culture of quality and compliance throughout the organization Supports departmental and franchise objectives while adhering to the ASP core values as well as local safety and environmental policy and procedures Performs other duties assigned as needed Our Needs Here s what we ll need from you Minimum Requirements BS degree or equivalent in Engineering Life Sciences or related field is required MS degree is preferred Additional work experience in lieu of a degree may be considered Minimum of 6 years of experience in medical device or pharma regulated environment in the areas of Quality R D Manufacturing or related field At least 3 years of experience in the Medical Device industry Demonstrated knowledge of regulatory standards and regulations within the designated region is required Must have previous experience working with local health authority Ability to effectively negotiate and influence above below and across the organization Ability to work and communicate in a cross cultural environment Excellent communication skills both written and verbal Highly developed influence interpersonal communication and conflict resolution skills Ability to interact with all levels and disciplines within the organization Must be able to work on multiple priorities and tasks simultaneously while acting in a decisive manner and demonstrating a bias for action High sense of urgency adaptable to meet rapidly changing priorities Proven analytical quantitative skills Project management skills with the ability to drive change and influence decision making through multiple levels Fortive is a global family of more than 20 industry leading industrial growth and technology companies united by a shared purpose to make the world stronger safer and more effective by providing essential technology for the people who accelerate progress Here you get the excitement of a startup with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth There s no limit to what you can learn or the impact you can make for you for us for growth Come join our team at Advanced Sterilization Products ASP and be part of a global leader in infection prevention solutions for the healthcare industry With advanced products technologies and workflows for medical sterilization and disinfection ASP is dedicated to defending the lives of patients families healthcare workers providers and communities Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone ASP is based in Irvine California with core sites in Everett Washington and Schaffhausen Switzerland plus many more offices around the world

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