CAPA Engineer

Job Description

Job title:

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.

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/administrative role.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.