PQV Combination Product Analyst IV

The PQV Combination Product Analyst IV at Johnson & Johnson is a role focused on managing and improving product quality and safety. The company is a global leader in healthcare, dedicated to developing innovative medical solutions and treatments. Their mission is to enhance health outcomes through a combination of medicine and medical technology. The primary tasks of the PQV Combination Product Analyst IV involve handling a high volume of product quality complaints and adverse events. This includes assessing Medical Device Reporting (MDR) and ensuring the completeness and consistency of complaint documentation. The role also involves collaborating with various teams, such as Clinical, PV, IT, and R&D, to drive process improvements and manage changes effectively. The analyst will lead projects, communicate with management, and ensure that complaint and MDR processes are accurate, efficient, and timely. To qualify for this position, candidates must have a strong background in quality assurance, with specific experience in handling product quality complaints and MDR assessments. Proficiency in risk assessment and the ability to lead projects and communicate effectively with stakeholders are essential. The role requires a deep understanding of regulatory requirements and the ability to perform technical evaluations. Fluency in English is a must, as is the ability to work independently and drive process improvements. Nice-to-have skills include experience with statistical/data-driven processes and the ability to use Process Excellence tools. The role offers opportunities for growth and development, with the chance to work on special projects and lead remediation activities. The position is based in multiple locations, including Beerse, Antwerp, Belgium, Ringaskiddy, Cork, Ireland, and Schaffhausen, Switzerland, providing a diverse and inclusive work environment. What the role asks for: - Experience in quality assurance, specifically in handling product quality complaints and MDR assessments. - Ability to lead projects and communicate effectively with stakeholders. - Proficiency in risk assessment and technical evaluations. - Fluency in English. - Experience with statistical/data-driven processes (nice to have).