PQV Combination Product Analyst IV

The PQV Combination Product Analyst IV at Johnson & Johnson is a pivotal role within the Quality Assurance team, focusing on healthcare innovation. The company is dedicated to advancing healthcare solutions, from preventing and treating complex diseases to developing smarter, less invasive treatments. This role is crucial for maintaining the high standards of quality and safety in their products. The primary tasks of the PQV Combination Product Analyst IV involve managing high-volume end-to-end product quality complaints and adverse events. This includes assessing Medical Device Reporting (MDR) and ensuring the completeness and consistency of complaint and MDR documentation. The role also involves collaborating with various stakeholders, such as the Outsourced Management Team, Clinical, PV, IT, and more, to drive process improvements and enhance the efficiency of complaint and MDR processes. The analyst will lead projects, communicate effectively with management, and support global change management initiatives. To excel in this role, candidates must have a strong background in quality assurance, with specific experience in handling high-volume product quality complaints and adverse events. A solid understanding of Medical Device Reporting (MDR) assessments is essential. The role requires proficiency in English, as well as the ability to work independently and lead projects. Familiarity with Process Excellence tools and the ability to execute statistical/data-driven processes are also crucial. Nice-to-have skills include the ability to challenge the status quo, identify gaps, and drive process improvements. The role offers opportunities for growth and development within a dynamic and collaborative team. The position is based in multiple locations, including Beerse, Antwerp, Belgium, Little Island, Cork, Ireland, and Schaffhausen, Switzerland, providing a diverse and inclusive work environment. What the role asks for: - Experience in handling high-volume product quality complaints and adverse events. - Proficiency in Medical Device Reporting (MDR) assessments. - Proficiency in English. - Ability to work independently and lead projects. - Familiarity with Process Excellence tools. - Ability to execute statistical/data-driven processes. - Nice-to-have: Ability to challenge the status quo, identify gaps, and drive process improvements.