In this role, you have the opportunity to
be responsible for Post Marketing Surveillance and compliance including complaints investigation, data analysis, monitoring and coordinating recall/field corrective action programs for medical products.
Prepares required documentation of field actions e.g., Health Hazard Evaluation documents, Correction and Removal documents, and product recall files.
Establish control and maintenance of all quality processes and measures related to Field Action. Responsible for the overall execution of the Complaints Handling& Reporting processes.
Position can be located at Haifa or Raanana
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
Monitoring and coordinating the different sub-system feeders to this process such as complaint handling, engineering change orders, regulatory submission and field deployment
Preparing key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports
Ensuring alignment between risk assessment and management documentations and documentation for field actions
Managing recall responses, recall file documentation and recall file completion
Providing 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 tracking field actions and provide ongoing information to Regulatory Operations as required
Establishing, monitoring and reporting on metrics on the efficacy and efficiency of field action processes
You are a part of
EDI (Enterprise Diagnostic Informatics) Q&R Organization. Our mission to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. We enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs. Our research and business provides unique opportunities to develop cutting-edge clinical solutions and deliver meaningful solutions in the healthcare space.
To succeed in this role, you should have the following skills and experience
Relevant academic degree
3 years experience in Quality positionsExperience with Complaints and/or Reporting – an advantage.
Experience working in Medical Device Company - an advantage
Knowledge of FDA Regulations - an advantage
Good verbal and written communication skills in EnglishGood communication skills and personal relationshipsAbility to work effectively with teams located worldwide
In return, we offer you
Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already.
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 https://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. Learn more by watching this video at 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 at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there, you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .