Quality CAPA Engineer (International Region role, based in San Juan, Puerto Rico) The role is focused on ensuring the CAPA subsystem is in control, and that actual or potential non-conformities are addressed - focused on medical devices that are already on the market.
Your role:
Drive and/or own corrective and preventive actions.
· Lead cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
· Work cross-functionally with global stakeholders to ensure timely resolution of all CAPAs.
· Report to senior management on status of CAPAs.
· Be ambassador of the Philips quality policy within the organization.
· Participate in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
· Take ownership of basic processes in the assigned area/areas to ensure that QMS is efficient and meets the regulatory requirements.
You're the right fit if:
1. You have a Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
2. Fluent/advanced English - You'll have to able to deal with stakeholders and teams based globally.
3. You have minimum 5 years of CAPA experience in highly regulated environments/industries such as medical devices, Pharma, Automotive.
4. You have a proactive and entrepreneurial mindset, and act fast on potential issues.
5. You have extensive experience in working with commercial functions and service/installation functions within the organization.
This is an Office/administrative role.
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.
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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 .
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