Alajuela, CRI
3 days ago
Senior Process Quality Engineer
The Senior Process Quality Engineer will play a key role in strengthening quality processes, supports high-quality performance and compliance across our factories/manufacturing operations. **Your role:** + Lead non-conformance investigations, manage QNs, and drive effective CAPA to prevent recurrence. + Drives change management, monitors operational performance, leads defect and non-conformance analysis, and supports investigations and CAPA implementation. + Own risk management, validation activities, and MRB processes to ensure product quality and compliance. + Monitor quality performance, build dashboards, and report key metrics to senior leadership. + Partner cross-functionally with R&D, Manufacturing, and Supplier Quality to resolve systemic issues. + Act as SME in audits, strengthen quality systems, and mentor junior quality staff. **You're the right fit if:** + You have a minimum of 5+ years’ experience working in FDA regulated Quality/Manufacturing environments, with a focus in quality operations, audit support, process validation/improvement, CAPA, non-conformance and Change/Risk Management (ISO 14971). Experience in Software validation desired. + You're fluent in English (verbal and writing), with strong presentation and influencing skills. + You’re experienced in data analysis/statistics, reporting on key metrics/KPI’s, data visualization/dashboards, and experienced with data analytics tools such as Power BI. + You have a minimum of a Bachelor's degree in Quality, Engineering, or comparable disciplines. Master’s Degree is a plus. + You have proven experience leading cross-functional teams and the ability to mentor less experienced engineers. + You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this **position** **.** **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 4 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 role 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.
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