Job TitleCAPA 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 investigationsEnsures the investigation is supported with objective evidence and supporting records and an aligned accepted action plan.Meet all the Quality standards for CAPA ExecutionMaintain the documents of CAPA into Quality Case Management (QCM) tool.Communicate the progress of CAPA to all the relevant stakeholdersClear 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 / strategyCo-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 environmenta 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 industryExperience of maintaining the Quality Case Management (QCM) toolUnderstanding of CAPA process, key steps, and criteria for successExperience of problem solving techniques and toolsa minimum of 5 years’ experience in equipment, labs, and facilitation & requirement definitionExperience in new product introduction or life-cycle development in the industryBeing a team player with good managerial skills (soft skills)Good communication skills in EnglishDrive for quality and continues improvementTeam 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. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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