Capa Owner

### Job Title CAPA Owner ### Job Description **In this role, you have the opportunity to** develop electrical (sub-) systems and solutions (including their validation, testing and troubleshooting) for Interventional Guided Therapy systems (fixed interventional X-Ray systems). You will work within a multi-disciplinary team on applying research results and technology advancements to improve and release new advancements of Philips IGT Systems. Our system need to fulfill all applicable international standards. **You are responsible for** * Primarily responsible and accountable to Independently execute a CAPA from Ownership acceptance until closure. * You will be the leading the team of subject matter experts driving multiple CAPA investigations collaborating across functions. * Responsible for ensuring the CAPA deliverables and timelines are resources and met. * Creates the CAPA plan to optimum utilization of CAPA resources to solve complex and critical issues. * Align on Team Way of Working: Best practice is to treat the Investigation phase similar to a workshop / kaizen. * Leads the progress for the assigned CAPA for the robust and quicker solutions. * Use of best approach for key deliverables such as root cause investigations * Ensures the investigation is supported with objective evidence and supporting records and an aligned accepted action plan. * Meet all the Quality standards for CAPA Execution * Maintain the documents of CAPA into Quality Case Management (QCM) tool. * Communicate the progress of CAPA to all the relevant stakeholders * Clear communication and successful cooperation with your colleagues in India and Europe, or any other part of world.  * Co-creating, maintaining and carry out the CAPA team vision / mission / strategy * Co-create, maintain, and improve your facilities (labs, equipment, quality of own and suppliers) * Successful cooperation with your internal / external customers **You are a part of** CAPA Team - Pune Department within the Mechatronics Development Cluster of R&D IGT Systems in Best, Netherlands. The department consists of an open and multi-cultural team working on lifecycle management (PQ&M) and new product introductions (PDLM ). **To succeed in this role, you should have the following skills and experience** * An Engineering degree in Mechanical/Electrical/Electronics/Mechatronics or related discipline. * a minimum of 14+ years of relevant experience in professional engineering environment * a minimum of 5 years’ experience in Quality management systems of Medical devices (preferable in ISO13485:2016) * a minimum of 5 years’ experience in development (preferable experience in IEC60601-1) * Work experience of Handling the CAPA into regulated industry * Experience of maintaining the Quality Case Management (QCM) tool * Understanding of CAPA process, key steps, and criteria for success * Experience of problem solving techniques and tools * a minimum of 5 years’ experience in equipment, labs, and facilitation & requirement definition * Experience in new product introduction or life-cycle development in the industry * Being a team player with good managerial skills (soft skills) * Good communication skills in English * Drive for quality and continues improvement * Team engagement **In return, we offer you** with the opportunity to expand your professional experience. In our competence areas, we can offer you stimulating challenges across a wide range of application domains, interesting variation, job satisfaction and the chance to broaden your experience – all within one company. The opportunity to shape and grow your career will be in your own hands. **Why should you join Philips?** Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the [health continuum](https://www.philips.com/b-dam/corporate/corporateblog/2016/Philips_Chronic_Disease_5.jpg). Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by [watching this video](https://youtu.be/ocnMFp1JBuM). To find out more about what it’s like working for Philips at a personal level, visit the [Working at Philips page](https://www.careers.philips.com/professional/global/en/workingatphilips) on our career website, where you can read stories from our [employee blog](https://www.careers.philips.com/global/en/blog-unexpected). Once there,you can also learn about our [recruitment process](https://www.careers.philips.com/global/en/recruitmentprocess), or find answers to some of the [frequently asked questions](https://www.careers.philips.com/global/en/faq).