● Responsible for daily execution of Non-Conformities (NC) investigations and Corrective and Preventive Actions (CAPA) in collaboration with the Enterprise Quality Teams across Europe, Asia, North America and Latin America.● Provide compliance support and quality insights to QMS, R&D, Engineering, and Quality & Compliance, ensuring investigation, resolution, and documentation of individual quality issues and trends.● Create and update Quality System documentation, including SOPs, WIs… Show more ● Responsible for daily execution of Non-Conformities (NC) investigations and Corrective and Preventive Actions (CAPA) in collaboration with the Enterprise Quality Teams across Europe, Asia, North America and Latin America.● Provide compliance support and quality insights to QMS, R&D, Engineering, and Quality & Compliance, ensuring investigation, resolution, and documentation of individual quality issues and trends.● Create and update Quality System documentation, including SOPs, WIs, Standards, and Guidelines, as well as NC and CAPA reports.● Deliver feedback on compliance risks to QMS processes and procedures, conducting trend analyses of incidents at defined intervals to identify individual quality concerns.● Build strategic partnerships with managers and directors to support quality issue identification and resolution.● Support inspection preparation for the QMS incidents, reliability, NC, and CAPA, and communicate key messages to cross-functional teams.● Identify gaps in scope-related systems and processes, proposing improvements and raising critical quality issues. Show less

● Managed the quality team for cardiac valves assembly, packaging, and sterilization.● Utilized data-driven problem-solving techniques and presented findings to senior management.● Supervised, managed and coached members of the quality team.● Provided updates to leadership team on critical issues and project progress.● Ensured manufacturing compliance by focusing on nonconformances, corrective and preventive actions, and the resolution of quality incidents through the CAPA… Show more ● Managed the quality team for cardiac valves assembly, packaging, and sterilization.● Utilized data-driven problem-solving techniques and presented findings to senior management.● Supervised, managed and coached members of the quality team.● Provided updates to leadership team on critical issues and project progress.● Ensured manufacturing compliance by focusing on nonconformances, corrective and preventive actions, and the resolution of quality incidents through the CAPA process.● Participated in discussions on regulatory issues as well as customer complaints related to manufacturing changes and design impacts.● Collaborated with various functions, including R&D, Regulatory Affairs, Product Development and Manufacturing/Operations.● Prepared cross-site teams for audits to ensure full regulatory compliance. Show less

● Developed, implemented, and trained distribution center teams in key elements: Leader as Role Model, Change Management, Customer Focus, Gemba, Mistake Proofing, Problem-Solving, Kaizen, Monitoring and Control, 5S, Visual Factoring, Value Stream Mapping, Human Performance, Never Pass a Mistake, and Rewards/Recognition.● Evaluated and approved quality documents and procedures to ensure compliance with established standards.● Managed quality audits for Latin America and served as primary… Show more ● Developed, implemented, and trained distribution center teams in key elements: Leader as Role Model, Change Management, Customer Focus, Gemba, Mistake Proofing, Problem-Solving, Kaizen, Monitoring and Control, 5S, Visual Factoring, Value Stream Mapping, Human Performance, Never Pass a Mistake, and Rewards/Recognition.● Evaluated and approved quality documents and procedures to ensure compliance with established standards.● Managed quality audits for Latin America and served as primary liaison for regulatory audits. Show less

● Developed and implemented quality policies to ensure compliance with international standards and exceed customer expectations.● Managed a multidisciplinary team to foster a culture of excellence and continuous improvement.● Performed risk assessments and audits to ensure compliance with regulations and market standards.● Collaborated with R&D, Manufacturing, and Operations to maintain high-quality standards.● Managed quality relationships with customers and suppliers to align… Show more ● Developed and implemented quality policies to ensure compliance with international standards and exceed customer expectations.● Managed a multidisciplinary team to foster a culture of excellence and continuous improvement.● Performed risk assessments and audits to ensure compliance with regulations and market standards.● Collaborated with R&D, Manufacturing, and Operations to maintain high-quality standards.● Managed quality relationships with customers and suppliers to align quality expectations.● Created and monitored KPIs to evaluate and report on the effectiveness of quality processes. Show less

● Managed the Quality Engineering team, providing leadership and guidance to over 20 engineers, from junior to senior levels, ensuring end to end quality monitoring.● Oversaw the validation of test methods, quality in sterilization using cobalt 60 and ethylene oxide, and quality assurance and supplier qualification● Served as the quality representative for the development and manufacture of Combined Products, such as a unique absorbable synthetic multifilament suture with potential… Show more ● Managed the Quality Engineering team, providing leadership and guidance to over 20 engineers, from junior to senior levels, ensuring end to end quality monitoring.● Oversaw the validation of test methods, quality in sterilization using cobalt 60 and ethylene oxide, and quality assurance and supplier qualification● Served as the quality representative for the development and manufacture of Combined Products, such as a unique absorbable synthetic multifilament suture with potential antiseptic activity due to surface coating with triclosan.● Played a key role as the QA representative for the Bone Wax development project, ensuring that the sterile blend of beeswax and isopropyl palmitate achieved local bone hemostasis.● Ensured quality assurance of catgut manufacturing facilities, monitoring the integrity of biological tissues (bovine intestines) through various stages of production.● Managed the cleaning validation project for the Suture Finishing site, working with a multidisciplinary team to meet FDA requirements.● Performed analysis, testing, and characterization of customer complaints, wrote technical reports, and maintained relationships with healthcare professionals through visits to hospitals and surgical centers. Show less

● Managed a team of electronics technicians, ensuring the effective distribution of tasks according to production schedules, with a 98% on-time equipment delivery rate.● Provided new employee training and certification.● Developed and implemented projects to improve efficiency and reduce costs, achieving an 80% improvement with zero nonconformances.● Identified, supported, and qualified suppliers of equipment and materials for the project.● Demonstrated the ability to prepare… Show more ● Managed a team of electronics technicians, ensuring the effective distribution of tasks according to production schedules, with a 98% on-time equipment delivery rate.● Provided new employee training and certification.● Developed and implemented projects to improve efficiency and reduce costs, achieving an 80% improvement with zero nonconformances.● Identified, supported, and qualified suppliers of equipment and materials for the project.● Demonstrated the ability to prepare technical documentation to obtain the CE mark from the European Commission. ● Provided new employee training and certification.● Developed and implemented projects to improve efficiency and reduce costs, achieving an 80% improvement with zero nonconformances.● Identified, supported, and qualified suppliers of equipment and materials for the project.● Demonstrated the ability to prepare technical documentation to obtain the CE mark from the European Commission. Show less