**Your role:** + Lead and support CAPA investigations end-to-end, including issue identification, root cause analysis (5 Whys, Ishikawa, statistical analysis), corrective actions, effectiveness checks, and closure in line with regulatory and QMS requirements. + Partner cross-functionally with Quality, Engineering, Manufacturing, Service and Commercial teams to ensure timely execution of CAPA actions, adequate resourcing, and sustained compliance. + Monitor and analyze quality data to identify risks, trends, and emerging non-conformances, enabling proactive compliance interventions and continuous improvement. + Strengthen the compliance culture by training and mentoring teams on QMS, CAPA, regulatory expectations, and best practices across the organization. **You're the right fit if:** + You have a minimum of Minimum of 5+ years of experience in FDA regulated manufacturing/quality environments, with a focus on CAPA investigations, Process improvement, Quality Management Systems, Audit support, and root cause analysis. + You have a strong Understanding of the end-to-end CAPA process, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485 EUMDR, and ISO9001. + You're able to analyze quality data to identify risks, trends, and emerging non-conformances + You have a minimum of a Bachelor's Degree in Engineering, Sciences, similar disciplines or equivalent. + You have advanced level communication in English (verbal/written). + You're able to commute to Philips Alajuela, Costa Rica site in Coyol free zone (3 days a week). **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office role. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.