At Merit Medical, our mission is to create innovative medical devices that improve lives
Job Summary
At Merit Medical, our mission is to create innovative medical devices that improve lives.
Responsible for Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR), Health Hazard Evaluation (HHE) Processes, and Field Correction Action and Recall (FCA) Processes.
As an eligible Merit employee, you can expect Medical/Dental & Other Insurances, a Low Cost Onsite Medical Clinic, and 3 Weeks' Vacation.
Matching Summary
At Merit Medical, our mission is to create innovative medical devices that improve lives.
Skills & Requirements
Must-have
Post Market Surveillance documentation
Health Hazard Evaluation Processes
Field Correction Action and Recall
Quality Management Sub-systems
Medical Device Product Evaluation
Regulatory Compliance Monitoring
Nice-to-have
Process Improvement Aptitude
Lean and Six-Sigma Tools
International Team Leadership
Clinical Harm Determination
Continuous Improvement Initiatives
Key Requirements
Bachelor's degree in quality engineering / Biomedical engineering / science, nursing or equivalent
8 years of work-related experience in medical device industry
5 years in a supervisory, leadership or management role
Knowledge of U.S. FDA regulations
Knowledge of European Medical Device Regulation 2017/745 (MDR)
Knowledge of ISO 13485 Quality System Standards
Knowledge of ISO 14971 Risk Management
Experience with electronic data management systems