Responsibilities may include the following and other duties may be assigned:
Work with the Integration Lead on integration planning for quality systems, processes, and documentation, ensuring alignment with our QMS, regulatory requirements, and integration objectives.
Lead the mapping, migration, and harmonization of CathWorks quality processes, including document control, training, audits, CAPA, complaints handling, and design control activities, ensuring compliance with FDA, MDR, ISO, and our standards.
Oversee CAPA and complaints management processes, including root cause analysis, corrective and preventive actions, regulatory reporting, and continuous process monitoring.
Provide oversight of software development lifecycle processes, including requirements management, design reviews, validation, testing, and software design controls in regulated environments.
Ensure all quality activities comply with applicable regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk management, audit readiness, and support for internal and external audits.
Facilitate communication, training, and stakeholder engagement across CathWorks and Medtronic, identify process gaps, drive continuous improvement initiatives, and monitor integration progress through metrics and regular reporting.
Bachelors degree in Engineering, Life Sciences, or a related field; Masters degree preferred.
7+ years of experience in medical device quality management, including QMS integration, design controls, CAPA, complaints management, and software validation.
Strong knowledge of FDA regulations, MDR ISO 13485, and 21 CFR Part 11 requirements.
Demonstrated project management and leadership skills, with the ability to drive cross-functional initiatives.
Excellent communication, stakeholder management, and change management skills, with the ability to influence and engage diverse stakeholders.
