CAPA Owner

Within Philips Healthcare in Best, the Business Unit Image Guided Therapy Systems (IGT-S) is responsible for marketing, development and manufacturing of X-ray systems in the area of cardiac or vascular medical diagnosis and (minimally invasive) interventions.  The customers are hospitals, medical specialists and universities. Philips Healthcare develops and manufactures best-in-class medical products. One of its successful products is the Azurion platform. This platform allows our customers to perform procedures easily and confidently with unrivaled user experience, helping them to optimize lab performance and to provide superior care.

This role is in the Imaging Chain Cluster (ICC). The Imaging Chain Cluster is responsible for the real time image acquisition, processing, rendering and video distribution of our X-ray systems.

As a CAPA Owner in IGT-S, you will play a pivotal role in ensuring the quality, safety, and compliance of our products. You will lead the Corrective and Preventive Action (CAPA) process, driving investigations, root cause analyses, and implementation of robust corrective and preventive measures. As CAPA owner you will drive the CAPA as assigned to you effectively to closure. Your expertise and commitment will be essential in maintaining regulatory compliance, enhancing product quality, and safeguarding patient health.

Your role:

• CAPA Leadership: Take ownership of the CAPA investigation and implementation according to process, serving as the primary point of contact for all activities related to your CAPAs. Lead cross-functional teams to investigate, assess, and resolve quality issues promptly and effectively.

• Root Cause Analysis (RCA): Conduct thorough root cause analyses using industry-standard methodologies such as 5 Whys, Fishbone diagrams, or Failure Mode and Effects Analysis (FMEA). Identify underlying factors contributing to quality deviations or non-conformances.

• Data Analytics: Utilize data analytics tools and techniques to analyze quality data, identify trends, patterns, and correlations related to root cause finding. Relevant data is information such as system logging, complaints, defects, installed base data, replacement rates, etc, etc.

• Project Management: Develop comprehensive action plans to address identified root causes and prevent recurrence of quality issues. Collaborate with relevant stakeholders to define corrective and preventive measures, setting clear objectives, timelines, and responsibilities. Ensure timely and effective implementation of CAPA actions across all relevant departments or functions. Drive and monitor progress, provide guidance as needed, and escalate issues impacting implementation timelines or effectiveness.

• Good Documentation Practice and Reporting: Maintain accurate records of all CAPA activities, including investigation findings, action plans, and verification/validation activities. CAPA documentation must be complete, concrete, and concise. Prepare thorough documentation for regulatory submissions and internal audits. Generate reports to communicate CAPA status, trends, and metrics to all relevant stakeholders.

• Regulatory Compliance: Stay abreast of regulatory requirements and industry standards related to quality management systems (QMS), medical device regulations, and Good Manufacturing Practices (GMP). Ensure CAPA records align with applicable regulations and standards, facilitating successful regulatory inspections and audits.

• Continuous Improvement: Drive a culture of continuous improvement within the organization by identifying opportunities to enhance the effectiveness and efficiency of the CAPA process. Leverage data analytics insights to identify areas for process optimization and quality enhancement. Implement best practices, lessons learned, and feedback mechanisms to foster a proactive approach to quality management.

You're the right fit if:

• At least Bachelor's degree in Software Engineering, Biomedical Engineering or a related field. Advanced degree is preferred.

• Extensive experience (5+ years) in Research and Development within the medical device industry, with a focus on structural problem-solving methodologies.

• Proven expertise in root cause analysis techniques and problem-solving methodologies.

• Project management skills, with the ability to lead cross-functional teams and drive initiatives to completion.

• Conceptual thinking level; quickly adapt to new knowledge area; able to decompose a problem into smaller work packages, if needed with the support of Subject Matter Experts.

• Good communication and interpersonal skills, with the ability to influence stakeholders at different levels of the organization.

• Understanding of quality management principles, methodologies, and regulatory requirements (e.g., FDA 820.x, ISO 13485, IEC62304 standard).

• Certification in quality management (e.g., ASQ Certified Quality Engineer, Six Sigma Green or Black Belt) is a plus.

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 youâre 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 commitment to diversity and inclusion here.

#LI-EU

#LI-Hybrid