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Job Title
Sr. Systems Engineer / Sr. CAPA Engineer (software)
Job Description
As a Senior Systems/CAPA Engineer you will provide technical leadership to development and maintenance of our Allura and Azurion x-systems used in the area of cardiac or vascular medical diagnosis and treatment (e.g. balloon angioplasty and stent procedures).
In this role you will start with leading the Corrective and Preventive Action (CAPA) process, driving investigations, root cause analyses, and implementation of robust corrective and preventive measures. You will also 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. We are seeing this role as an excellent way to get introduced in our systems, processes, and organization, enabling you in a leading technical role in the System Design Cluster in the next step in your career.
With your software background, you will focus on CAPA’s related to hardware malfunction of our systems.
Your role:
CAPA Leadership: Take ownership of the CAPA investigation and implementation according to process, serving as the primary point of contact for all CAPA-related activities across the organization. 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 will be part of the IGT-S System Design Cluster. The System Design cluster is responsible for the upper side of the V-model, which includes definition of System Requirements and Design, Verification, Validation, and release.
You're the right fit if:
At least Bachelor’s degree in Software Engineering. Advanced degree 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.
Strong 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.
Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels of the organization.
Demonstrated leadership abilities, including coaching, mentoring, and fostering a culture of quality and compliance.
Certification in quality management (e.g., ASQ Certified Quality Engineer, Six Sigma Black Belt) is a plus.
In-depth knowledge of quality management principles, methodologies, and regulatory requirements (e.g., FDA QSR, ISO 13485).
This role can be performed in a hybrid way of working.
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.
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If you’re 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 .
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