Job Description

JOB SUMMARY:

• Be a key developer in expanding our Quality and Regulatory Risk Management team for our IGTD organization. Create and implement new tools and methods to manage risk, which will contribute to the safety and efficacy of medical products that save lives and improve health

RESPONSIBILITIES:

• Collaborate at a systems level with Quality, R&D, Clinical, 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 Risk Management tools, assessment, processes, and principles, including FMEAs
• Conduct analysis of 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 procedures
• Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes

MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:

• Bachelor of Science in Engineering or a related field
• 2+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry
• 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
• Experience working within a Quality Management System
• Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders
• Proficiency with Microsoft Excel and Word
• Experience working with PLM systems (e.G. Windchill), statistical software, and complaint management tools