Edwin Martinez Email & Phone Number

Florida, United States

Bradenton, Fl

Managed all Quality Assurance and Regulatory Affairs activities for a Class 1 Digital Recording Systems for medical applications. Responsible for the implementation and maintenance of ISO 13485 Quality System and 21 CFR Part 820. Conduct all international and domestic registration activities for product sales and distribution purposes. Conduct and coordinate internal and external Quality Audits, as well as supplier audits from our main distributors.

Lead Boston Scientific QA and QE team defining and implementing a strategy to reduce $3KK of finished product inventory in backlog due to unresolved NCMRs. Scheduled & conducted daily meetings to work with pre-defined teams to identify ways to remove barriers, facilitate functional approaches for investigations, root cause analysis, corrective actions, solution implementations, and other actions pertaining to the NCMR. Designed and implemented NCMRs metrics to track NCMR closures daily, and to enforce a mindset of real time investigation while ensuring improvements were sustainable. Reduced backlog from $3KK and 388 NCMRs to $650K and 115 NCMRs (average # of NCMRs generated weekly) in four months. Reached and sustained real time (3-5 days NCMR investigation to complete), while completing much more robust NCMR investigations.

Managed all Quality Assurance activities and key Regulatory Affairs functions (ea. Complaints, Product Correction and Removals, and MDRs) with 4 direct reports and 14 associates, and with a $1.5m budget for the Lakeland, FL facility. Responsible for compliance with U.S. FDA regulations, ISO13485:2003 standards, and OSHA. Effectively transitioned compliants investigations from the R & D team into a QA function. Significantly improved Internal Asessments program by creating multidiciplined teams

Bs, Biology, General

Bachelor Of Science (Bs), Biology/Biological Sciences, General