QA Engineer - Risk Management

5 months ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Responsibilities Be a key developer in expanding our Quality & Regulatory Risk Management team for our Sleep and Respiratory Care organization. Create and implement new tools and methods to manage risk, contributing to the safety and efficacy of medical products that save lives and improve health. Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management. Lead cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File. Facilitate the creation of risk management tools, assessments, processes, and principles, including FMEAs. Analyze existing similar products from the company and competitors to provide documented compliance and evidence of State of the Art for periodic risk management updates. Ensure products meet regulatory requirements such as FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures. Convert customer requirements into product specifications and post-market surveillance codes systematically and logically. Develop and improve procedures and work instructions to ensure reliable, repeatable results, supporting compliance initiatives including CAPAs across the Connected Care business groups. Contribute to the organization's mission to develop innovative health technologies that positively impact billions of lives annually. Lead teams, drive projects, think strategically, and inspire colleagues worldwide in alignment with Philips' mission to improve lives through innovation. Requirements BS in Engineering or a related field; MS preferred. 6+ years of experience in Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related fields in a highly regulated industry. 2+ years' experience with an MS or higher degree. Hands-on experience with the ISO 14971 standard. Knowledge of standards such as 21 CFR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304. Strong understanding of risk management tools, methodologies, and processes. Experience managing complex projects and implementing cultural change. Excellent interpersonal and presentation skills. Experience within a Quality Management System. Green Belt or Black Belt certification preferred. Strong teamwork skills and stakeholder influence abilities. Seniority level Mid-Senior level Employment type Contract Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr