Quality Manager, Latin America

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitor follow our social channels on- LinkedIn,- Facebook,- Instagramand- XWhy join us?A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees.- Reporting to the Director, Distribution Quality Management, the Quality Manager of Latin America will focus on standardizing and deploying best in class quality processes and communications across the Latin America region. In addition to maintaining a compliant quality system, this person will lead the engagement and interaction with key internal customers specifically Regulatory Affairs, Operations Quality, Design Quality, and Post Market Surveillance teams along with key external customers. This leader will drive alignment on quality related processes, targets, and goals. This role is crucial for ensuring consistent quality standards across the Latin America region, maintaining regulatory compliance, and fostering continuous improvement to support embecta's mission of empowering people through innovative medical solutions.- RESPONSIBILITIES:_- The Quality Manager of Latin America will be responsible for managing the following activities:- Ensuring compliance with ISO 13485 and 21CFR 820 process- Verify that the distribution center and Latin America regional offices adhere to global and regional quality standards, including Good Distribution Practices (GDP).- Identify and mitigate quality risks in logistics and warehousing.- Drive initiatives to improve quality performance and reduce errors or complaints.- Conduct routine on-site quality oversight at the regional Distribution Centers, with travel required approximately once or twice per month (equivalent to ~10-20% travel time), to ensure compliance with quality systems, support continuous improvement initiatives, and maintain inspection readiness.- Management Representative for embecta Mexico- Compliance with importer requirements for Mexico- Working with Post market surveillance to ensure complaints compliance and PMS processes are effective and fit for purpose in the Latin America region.- Ensure compliance with regulatory requirements and internal quality standards. This includes maintaining up-to-date documentation and records, conducting regular reviews, and implementing corrective actions promptly.- Drive successful outcomes in all internal and external audits. Including preparing thoroughly for audits, addressing any findings swiftly, and continuously improving processes to prevent recurrence of issues.- Implement quality improvement initiatives. The initiatives should focus on enhancing quality compliance, efficacy and safety of embecta’s products by streamlining processes, and reducing process defects or non-conformities.- Foster improvement in key quality metrics, such as defect rates, audit findings, and cycle times for issue resolution.- Ensure embecta associates are compliant with training. This includes governance of training plans, tracking progress, and ensuring training is relevant and up to date.- Positive feedback from internal and external stakeholders, highlighting the effectiveness and consistency of quality systems.- Ensures the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization.- Establish and/ or revise processes, procedures, and metrics to support the global quality system and processes.- Establish excellent working relationships with quality, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations.- Contribute to the achievement of site objectives by playing an active role in the strategic planning process including the development of quality targets for continuous quality improvement- Monitors progress of the Quality KPI's and communicate it to the organization and senior management- Develop the organizational structure and talent to execute the Quality imperatives while supporting the overall company needs.- Facilitate appropriate inspections and any external audits/assessments to ensure that the global Quality Management System is properly