- Amgen (Cambridge, MA)
- … - ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong background in documenting requirements and ... more
- Amgen (Thousand Oaks, CA)
- …Qualifications:** + High school diploma / GED and 8 years of risk management , engineering, and/or medical device experience OR + Associate's degree and ... more
- Olympus Corporation of the Americas (Center Valley, PA)
- …prevention and control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device ... more
- Sanofi Group (Cambridge, MA)
- … planning, hazard and harms list, Risk management reports ) and assists medical device sites in ensuring that risk management is performed in ... more
- Robert Half Technology (Skaneateles, NY)
- …frameworks. + Utilize a Systems Engineering-driven approach to achieve compliance with ISO 14971 ( medical device risk management ). + Ensure all ... more
- Terumo Medical Corporation (Somerset, NJ)
- …+ Bachelor's Degree and a minimum of 10+ years of Enterprise Risk Management or related experience required, preferably in medical device ; or equivalent ... more
- Teleflex (Morrisville, NC)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management , and medical device Quality Management Systems ... more
- Amgen (Thousand Oaks, CA)
- …Practices - 21CFR820 + Quality Management - ISO 13485 + Risk Management - ISO 14971 + EU Medical Device requirements - Council Directive ... more
- Amgen (Cambridge, MA)
- …Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC. + Strong understanding and experience ... more
- Amgen (Cambridge, MA)
- … (ISO 13485); + Risk Management (ISO 14971); + EU Medical Device requirements (Council Directive 93/42/EEC); + Medical Electrical Equipment (EN ... more
- Amgen (Cambridge, MA)
- …Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (Council Directive ... more
- System One (West Point, PA)
- …the device risk analysis from complaints. + Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and ... more
- AbbVie (North Chicago, IL)
- … Device Quality SME on software classification review board + Support risk management / FMEA activities for device software & mobile apps. + Drive change ... more
- AbbVie (Madison, WI)
- …with a high degree of competency + Maintain understanding of medical device /combination product risk management regulations, as well as applicable ... more
- Sanofi Group (Cambridge, MA)
- …Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as ... more
- UCLA Health (Los Angeles, CA)
- Description The medical device security specialist will play a crucial role in safeguarding our medical device environment to ensure device integrity ... more
- Medtronic (Los Angeles, CA)
- …devices. Lead the work to security monitoring and secure operation of connected medical device systems. At Medtronic Diabetes, our IoT solutions, Application and ... more
- Integra LifeSciences (Plainsboro, NJ)
- …advance patient outcomes and set new standards of care. The **Quality Engineer - Medical Device / Pharma** will provide Plant Quality compliance support for the ... more
- Children's Hospital & Research Center Oakland (Oakland, CA)
- …or network administration (one or more) to understand potential medical device /system cybersecurity issues and qualify their risk appropriately. Based on ... more
- US Tech Solutions (San Bruno, CA)
- …with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management , Design/Process Verification, ... more
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