PQV Combination Product Analyst IV

The PQV Combination Product Analyst IV at Johnson & Johnson is a role focused on ensuring the quality and safety of combination products. The company is dedicated to advancing healthcare through innovative medicines and medical technologies, aiming to prevent, treat, and cure complex diseases with smarter, less invasive solutions. The primary responsibilities of this role involve managing high-volume end-to-end product quality complaint activities and adverse events. This includes performing Medical Device Reporting (MDR) assessments, providing guidance to the team, and ensuring the completeness and consistency of complaint and MDR documentation. The analyst will collaborate with various stakeholders, including business partners and external manufacturing sites, to drive process improvements and ensure the accuracy, efficiency, and timeliness of complaint and MDR processes. Additionally, the role involves risk assessing the impact of proposed changes to these processes and supporting global change management. To qualify for this position, candidates must have a strong background in quality assurance, with specific experience in handling high-volume complaint activities and MDR assessments. Proficiency in performing technical evaluations and ensuring compliance with regulatory standards is essential. The role requires effective communication skills to interact with all levels of management and stakeholders, as well as the ability to lead projects and drive process improvements. Nice-to-have skills include experience with statistical/data-driven processes and the ability to use Process Excellence tools to identify gaps and drive improvements. The role offers opportunities for professional growth and collaboration with a diverse team, contributing to the overall quality and safety of Johnson & Johnson's products. What the role asks for: - Experience in handling high-volume end-to-end product quality complaint activities. - Experience in performing Medical Device Reporting (MDR) assessments. - Ability to lead projects and communicate effectively with all levels of management. - Proficiency in performing technical evaluations and ensuring compliance with regulatory standards. - Experience with statistical/data-driven processes (nice to have). - Ability to use Process Excellence tools to identify gaps and drive improvements (nice to have).