Job Title
Product Hold and Post Market Risk Specialist
Job Description
In this role, you have the opportunity to
Be part of a fast-growing business that helps to improve the lives of millions of people.
Being part of the IGT Systems team will allow you to work with cross functional teams to support post-market risk assessments and timely decisions to segregate and disposition non-conforming product ensuring patient safety and product quality.
You are responsible for
* Participating as the PMS representative in the preparation, authoring (when applicable) review and approval of Post Market Risk Assessments and Health Hazard Evaluations.
* Collaborating with key stakeholders required for the execution of Post Market Risk Assessments such as Development, Risk Management and Medical Affairs.
* Supporting consistency of decisions of Health Hazard Evaluation, Product Hold and Field Safety Corrective Actions.
* Managing the Product Hold process for IGT-Systems (Fixed System) for products manufactured in Best (Netherlands).
* Managing the collection of the information required for the Hold determination and the facilitation of Product Hold initiation meetings.
* Being a back up for the creation of documentation required by the Product Hold process (e.g. Hold initiation form, Communication form, UAL and Hold closure forms).
* Supporting the identification and maintenance of appropriate metrics on the efficacy and efficiency of the Post Market risk assessment and Product Hold activities and monitoring and reporting on those metrics.
You are a part of
You will be part of the Post Market Surveillance Team, a young, dynamic and multicultural team.
To succeed in this role, you should have the following skills and experience
* Bachelor’s degree in biomedical engineering, science, healthcare, or medical profession.
* 5 years’ experience in Quality in Medical Device and/or other regulated industry preferably in Risk Management, Design Quality or Correction and Removal/Recalls or product development.
* Focus on detail.
* Good analytical skills and process improvement capabilities
* Teamwork in and outside Quality.
* Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).
* High degree of initiative, engagement, self-motivation and flexibility.
* Able to work in a changing environment and be a driver of change.
* Product Knowledge is preferred.
In return, we offer you
A path towards your most exciting career, giving you the opportunity to grow within the PMS team and Philips. A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.
How we work together
We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
#LI-EU
#J-18808-Ljbffr