In this role, you have the opportunity to Monitor and coordinate the different sub-system feeders to this process such as complaint handling, engineering change orders, kit suppliers, regulatory submission and field deployment. Manages recall responses, recall file documentation and recall file completion
You are responsible for
•Ensuring that processes for specifying and executing field actions are adequate to ensure the expectations of all key stakeholders are met.
•Monitors and coordinates the different sub-system feeders to this process such as complaint handling, engineering change orders, kit suppliers, regulatory submission and field deployment. Manages recall responses, recall file documentation and recall file completion.
•Prepares key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports
•Continuously track field actions and provide ongoing information to FCO team as required
•Ensures alignment between risk assessment and management documentations and documentation for field actions
•Manages recall responses, recall file documentation, recall file completion.
•Provides relevant feedback and insights from customers/filed to development/engineering teams to ensure learnings from previous projects are captured, synthesized and made available for next project teams.
•Continuously tracks field actions and provide ongoing information to Regulatory Operations as required.
You are part of progressive & energetic Quality & Regulatory team that contributes directly to the growth of the business. With global headquarter of Mobile Surgery, Philips HIC, Pune is playing a key role in Philips global strategy for Image-Guided Therapy. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips commitment towards Indian and growth healthcare markets
To succeed in this role, you should have the following skills and experience
Master/Bachelor in Engineering
Several years of experience in Quality systems for Medical devices.
Working knowledge of appropriate global medical device regulations requirements, and standards such as ISO 13485 and FDA QSR.
Project management experience is preferred.
Fast learner and interest to learn new technologies/business/systems.
System thinking mindset and domain expertise in the related area.
Excellent communication skills
Leadership skills and drive for results
Mindset to simplify and reach to solutions with speed.
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 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .