What are the responsibilities and job description for the Quality Engineer position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.
- Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
- Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
- nalyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
- ssure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
- Ensure the systematic and logical conversion of customer requirements to product specifications and post-surveillance codes.
- Create and continually improve procedures and work instructions to ensure reliable, repeatable results. Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.
Requirements :
