Risk Management Specialist
- Full Time
- Naples, FL
- Job ID:
We are currently seeking experienced Risk Management Specialist for our renowned Client, located in a beautiful office in Southwest Florida. This Risk Management Specialist will be working on very highly visible projects that will directly impact the organization by designing, coordinating, and maintaining various aspects of medical device programs.
Among other related tasks, this Risk Management Specialist can expect to:
- Follow global policies when developing processes for medical devices
- Create and manage device risk management files with the requirements of ISO 14971
- Lead product safety review board activities
- Generate HHE to appropriately document hazards
- Partner with multiple departments to ensure adequacy of quality management system documentation
- Act as the representative for risk management process during audits
- Analyze product design and quality data
- Participate in design reviews
- Provide support to design and manufacturing teams to apply to dFMEA, pFMEA, Fault Tree Analysis, etc.
- Support the development of test plans, design documentation reviews, and risk mitigation execution
This Risk Management Specialist should have:
- 5+ years of experience in risk management or related position
- Bachelor’s degree in engineering or related field
- Knowledge of FDA and ISO guidelines
- Knowledge of manufacturing process
- Knowledge of risk management requirements
- Knowledge of device clinical use and associated harms and hazards
- Previous experience in the medical device industry
- Excellent communication and problem-solving skills
This Risk Management Specialist will benefit from working with a hard-working team on highly visible projects in a positive environment and beautiful location.
Interviews are being scheduled immediately! Please contact one of our Recruiters today – (407) 215-0360 for additional information and consideration!