Quality
Quality Systems
Develop and implement intuitive and effective Quality Management Systems to satisfy applicable regulatory requirements (FDA QSR, EU MDR 2017/745, ISO 13485)
Determine the appropriate QMS rigor needed to ensure and maintain compliance based on device complexity and risk
Identify, assess and mitigate risk in existing QMS processes
Quality Assurance
Ensure appropriate processes are in place---and operating as intended---to maintain the safety and efficacy of marketed devices and achieve desired business results
Identify opportunities for improving existing processes, and implementing new ones as needed, to reduce/eliminate product and process non-conformances and increase efficiency
Supplier Relationship Management
Assess supplier QMS and manufacturing processes to ensure they product/material specifications and contractual requirements