Oversee Quality Management System (QMS) risk management activities. Provide cross-functional support across the QMS, manage day-to-day operations, and provide leadership and direction to the functional team. Monitor and prioritize projects and resources for risk management methods. Review and approve risk management records. Maintain the Risk Management QMS key process to ensure compliance with applicable regulatory requirements. Prepare, communicate and monitor risk management quality plans and metrics to support operations. Support all process owners in analysis, assessment and reporting of relevant risk information.
1. Expertise in risk management techniques per ISO 14971:2012/2019: hazard analysis using probabilistic methods of quantifying risk, d/p/u FMEAs, benefit-risk assessments, clinical evaluation reports, and other risk management tools for single-use, reusable, and electro-mechanical medical devices.
2. Experience supporting new product development and product/process remediation of single-use, reusable, and/ or electro-mechanical medical devices such as lithotripters, laser-fibers, catheters, stents, dilators, etc incorporating applicable standards, regulations, and guidance documents including ISO14971:2012/2019, 21CFR820, EU MDR, and applicable FDA guidance documents.
3. Experience in translating national and global regulatory and standard requirements into compliant and efficient quality management system procedures.
4. Experience supporting/leading internal and external audits, responding to regulatory inquiries, and interacting with notified bodies.
5. Ability to train employees on risk management concepts including but not limited to state-of-the-art assessment, AFAP, hazard analysis, post-market surveillance, etc.
6. Experienced in defending on-site internal and external audits and communicating with notified bodies to resolve non-conformances/queries.
7. Additional experience preferred: medical device testing in clinical setting; medical device manufacturing processes; data analysis with Excel, Minitab, or similar software, participation in national/international technical committees or standard organizations (AAMI, ISO, etc.).
8. Must have current authorization to be employed in the U.S. without employer sponsorship.
• Bachelor's degree in Engineering or Life Science
• Minimum of 7+ years experience in a regulated industry, preferably in a medical manufacturing environment
• Minimum 3 years experience working with quality management system
• Previous leadership experience, 5 years preferred
• Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects
• Works under general office environment conditions
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to stand, walk, and communicate
• Occasionally lifting with minimal exertion during shift