David Deangelo Email & Phone Number

Minneapolis, MN, US

Minneapolis, MN, US

Minneapolis, MN, US

• Applied project management and knowledge of regulations and external standards to guide and coach new employees in the development of compliant processes and procedures
• Analyzed and presented key metrics for complaint closure to senior management
• Developed cross-functional collaborative relationships to facilitate engagement, teambuilding, best practice sharing, critical thinking and innovative problem solving.
• Managed and drove accountability for process improvements within the Post Market Vigilance group
• Ran daily reports to ensure cross functional teams and the Post Market Vigilance group is performing their daily job functions
• Performed trending of complaint data and ensure issues are addressed during corrective action board (CAB) meetings

Minneapolis, MN, US

• Ensured that complaints were maintained and reported from initiation to completion with compliance to the FDA as well as other various international Medical Device Reporting authorities
• Worked collaboratively with quality engineering, regulatory affairs, clinical affairs, sales and legal to ensure compliance through timely and accurately managing of MDRs (Medical Device Reporting), MDVs (Medical.
• Monitored trending in complaint data to escalate new and emerging issues as necessary
• Ensured record documentation is maintained in a constant state of audit readiness per internal policies
• Performed follow up activities to obtain additional information on incoming complaints to fulfill Good Faith Requirement (GFE)
• Created tracking system for a clinical trial that involved a new stapling product line to monitor safety assessment and adverse events for 200 patients involved

Minneapolis, MN, US

• Subjected products in environmental testing to identify their capacity to withstand the rigors of harsh environmental conditions.
• Prepared and submitted various pertinent documents including environmental, bioburden, suture dry box, bacterial endotoxin, microbial, total organic carbon testing, and deviation trending issues
• Tested for bioburden load prior to sterilization of products
• Analyzed and trended for deviations and emerging issues in environmental conditions to escalate to management as necessary
• Organized and performed laboratory tests and procedures while maintaining strict alignment with good laboratory practice audits