Job Description

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.
• 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.
• Analyze 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.
• Assure 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 market 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.
• An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that positively impact billions of people every year. Including you.
• Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways.
• Our mission is to improve people's lives through meaningful innovation.
• We want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues worldwide.

• BS in Engineering or a related field. MS preferred.
• 6+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
• 2+ years' experience with an MS or higher.
• Extensive hands-on experience with the ISO 14971 standard.
• Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
• Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
• Demonstrated expertise in managing complex projects and implementing cultural change.
• Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
• Experience working within a Quality Management System.
• Green Belt or Black Belt certification preferred.
• Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders.

Job Tags

Similar Jobs