Job Title
ICC CAPA Owner/Scrum Master - Philips - Best
Job Description
Your role
As a CAPA Owner/scrum master in IGT-S, you will play a pivotal role in ensuring the quality, safety, and compliance of our products. You will have a twofold responsibility: to lead the Corrective and Preventive Action (CAPA) process, driving investigations, root cause analyses, and implementation of robust corrective and preventive measures, as well as to support the team in planning the activities, maintaining and prioritizing the backlog, communicating and aligning with the stakeholders, while ensuring the team can focus on their core activities. This twofold responsibility requires good in-depth content knowledge of our products and the scope of the projects; hence relevant background knowledge is essential. You will drive the CAPA’s 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. At the same time, you will ensure that the team gets all the support needed to focus on the right priorities.
Key Responsibilities:
* 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.
* 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.
* 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.
* 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.
* Support the prioritization and planning of the team activities, track the execution and maintain the backlog. Help to manage risks, dependencies and conflicts and escalates and tracks impediments w.r.t project/scrum teams.
* Stakeholder management: Work with Program/Product Management, Product Owners and other stakeholders to help ensure execution alignment.
* 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.
Your team
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 core of our X-ray systems, designing the imaging pipeline.
Qualifications and Skills:
* 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.
In return we offer you
A challenging and creative environment with great opportunities for you to explore. Our benefits are designed around your preferences.
* A competitive salary
* 25 Days of leave and the possibility to purchase up to 20 extra days off annually
* A variable bonus based on both Philips results and personal performance
* Extensive set of tools to drive your career, such as a personal development budget, free training and mentoring
* An international environment with colleagues who are the best in their field
* Attractive company pension scheme and attractive collective health insurance package
* Opportunity to buy Philips shares and products with discount
How we work at Philips
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.
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