Melisa Marenco Canet

• Led a high-visibility quality remediation project addressing an FDA 483 observation, coordinating cross-functional stakeholders and implementing four new controlled documents to strengthen compliance.
• Directed a team of 10 professionals (6 Engineers and 4 Investigators), fostering collaboration, talent development and continuous improvement.
  Improved organizational capability through strategic cross-training initiatives, increasing team versatility and supporting business continuity.
• Led cross-functional efforts to assess and address emerging quality issues, partnering with R&D, Design Quality Assurance (DQA), Regulatory Affairs, Manufacturing and Commercial teams to evaluate risks, drive investigations and implement effective solutions.

• Led global cross-functional initiatives to strengthen complaint investigation processes, partnering with Quality, R&D and Manufacturing teams to ensure compliance and drive continuous improvement.
• Directed and developed high-performing global teams, fostering collaboration, accountability and operational excellence while supporting business objectives and customer needs.
• Led high-impact remediation and process improvement projects, successfully reducing complaint backlogs, eliminating escalations, and improving overall team performance and efficiency.
• Improved organizational capability through standardization and knowledge-sharing initiatives, increasing investigation consistency, enhancing team effectiveness, and supporting long-term business sustainability.
• Collaborated with senior leadership and global stakeholders to assess risks, prioritize strategic initiatives and implement sustainable solutions to complex quality and compliance challenges.

• Managed non-conformances, CAPA activities, and quality system investigations, ensuring compliance with regulatory requirements and supporting product quality objectives.
• Led process improvement and risk mitigation initiatives, utilizing root cause analysis methodologies to identify systemic issues and implement sustainable corrective actions.
• Partnered with cross-functional stakeholders across Manufacturing, Quality, Engineering, and Operations to resolve complex quality challenges and drive continuous improvement.
• Supported internal and external audits, quality system compliance activities, and performance monitoring, contributing to the effectiveness and maturity of the Quality Management System.

• Led a team of 11 Quality Control Technicians, ensuring compliance with quality standards, supporting operational objectives, and driving a culture of accountability and continuous improvement.
• Developed and monitored quality performance metrics, providing data-driven insights to leadership and identifying opportunities to improve manufacturing performance and product quality.
• Partnered with Manufacturing, Engineering, and Quality teams to implement process improvements, resolve quality issues, and support the effectiveness of the Quality Management System.
• Managed non-conformance activities and quality investigations, driving timely resolution and supporting compliance with internal and regulatory requirements.

• Supported product transfer, validation, and quality compliance activities for new products and technologies within a regulated medical device environment.

• Managed global regulatory reporting activities, including MDRs and European Vigilance submissions, ensuring compliance with regulatory requirements.
• Analyzed complaint data and collaborated with cross-functional teams to support risk assessment and regulatory decision-making.

• Coordinated case management activities, resource planning, and escalations to support global service operations and customer satisfaction.

• Managed resource scheduling, workforce planning, and operational escalations to support field service teams and business objectives.