CAPA Engineer, Image Guided Therapy Devices

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.

Your role:

• 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.

You're the right fit if:

• You’ve acquired 5+ years of related experience with a bachelor’s degree or higher.
• Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and are experienced with ownership, facilitation or execution of the CAPA process within a medical device company.
• You have a bachelor’s or higher in Engineering, Science, or equivalent combination of education and related experience.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your CAPA expertise.

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-based role.