IGT-S ICC CAPA owner

Job Description

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.
• 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.
• 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.
• Regulatory Compliance: 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. 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 Physics, Electrical Engineering, Biomedical Engineering, Computer Science or a related field. Advanced degree preferred.
• Extensive experience (5+ years) in Research and Development within the medical device industry.
• 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.
• Proven expertise in root cause analysis techniques and problem-solving methodologies.
• 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).
• Experience in medical imaging or in understanding of X-ray physics and operation principles is considered a plus.
• Certification in quality management (e.g., ASQ Certified Quality Engineer, Six Sigma Green or Black Belt) is a plus.

How we work together
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

About PhilipsWe 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.