Philips CAPA Owner 

India, Maharashtra, Pune 

40812310

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

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