CAPA Engineer

Philips•San Diego, CA

1d•$92,000 - $163,000•Hybrid

About The Position

The CAPA Engineer is responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings for the Image Guided Therapy Devices business unit. Lead end-to-end CAPA investigations for product and process non-conformances, from issue identification through root cause analysis, implementation of corrective/preventive actions, and effectiveness monitoring. Ensure timely, accurate completion of CAPA records and supporting documentation. Project manages CAPA activities by coordinating cross-functional teams, securing resource commitment, and driving adherence to timelines and deliverables. Facilitate CAPA meetings and ensure alignment across stakeholders to advance resolution. Apply structured problem-solving and root cause analysis methodologies (e.g., PRIDE) while mentoring cross-functional teams to strengthen investigation rigor and decision-making. Support teams in developing robust, sustainable corrective and preventive actions. Analyze quality data trends using statistical techniques to identify systemic issues, emerging risks, and opportunities for prevention of non-conformances. Translate data insights into actionable CAPA strategies. Serve as the CAPA subject matter representative during audits and review boards while partnering with management to ensure action plans are feasible, resourced, and aligned with business priorities.

Requirements

5+ years of related experience with a bachelor’s degree or higher.
Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
Strong knowledge and experience with ownership, facilitation or execution of the CAPA process within a medical device company.
Bachelor’s or higher in Engineering, Science, or equivalent combination of education and related experience.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Excellent communicator, with an ability to influence cross-functional stakeholders utilizing CAPA expertise.

Responsibilities

Lead end-to-end CAPA investigations for product and process non-conformances, from issue identification through root cause analysis, implementation of corrective/preventive actions, and effectiveness monitoring.
Ensure timely, accurate completion of CAPA records and supporting documentation.
Project manages CAPA activities by coordinating cross-functional teams, securing resource commitment, and driving adherence to timelines and deliverables.
Facilitate CAPA meetings and ensure alignment across stakeholders to advance resolution.
Apply structured problem-solving and root cause analysis methodologies (e.g., PRIDE) while mentoring cross-functional teams to strengthen investigation rigor and decision-making.
Support teams in developing robust, sustainable corrective and preventive actions.
Analyze quality data trends using statistical techniques to identify systemic issues, emerging risks, and opportunities for prevention of non-conformances.
Translate data insights into actionable CAPA strategies.
Serve as the CAPA subject matter representative during audits and review boards while partnering with management to ensure action plans are feasible, resourced, and aligned with business priorities.