Risk Management Engineer (Freelance)

In this role, you have the opportunity to

Support R&D team with their risk management activities for the Azurion and Allura platform. This involves being a confident advisor on safety, compliance, quality and reliability related topics. Your efforts will contribute to our goal of delivering safe and high quality products and solutions to our customers and the patients they are treating so that they can go back to living the lives they love, faster. 

You are responsible for 

• Supporting the upgrade IGT Systems' Risk Management Files to the latest Philips standards 
• Supporting the safety compliance of the Risk Management Files to cover the complete medical system
• Support setting up an excellent connection of Risks to the Complaint Coding / Trending system.
• Hands-on support to transfer current FMEA documentation into a new FMEA structure. 
• Support assuring a complete and accurate linkage between design FMEAs and Risk Management Matrix and identifying missing risk assessments.

You are a part of
a fast growing and innovative Quality Assurance/Quality Engineering team within an ever-changing environment. This team has hubs in Best, Bangalore and Pune; and aims to continuously improve the safety, quality and reliability of IGT Systems' products and solutions. 

To succeed in this role, you should have the following skills and experience
We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life of the billions of people the Philips brand touches each year. Specific skill requirements for this role include:

• Master's degree in preferably a technical field, with 3+ years' experience in the medical industry.
• Demonstrated experience with Safety- and Design Risk Management conform (EN) ISO14971:2019
• Project Management skills. 
• Design Control experience conform 21 CFR 820 / (EN)ISO 13485:2016
• You are very analytical, critical and meticulous and possess a clear Team-up-to-Win mindset. 
• Effective interpersonal, written and oral communication skills expected.