Devin Stabile

Post Market Quality Specialist @Artivion, Inc.

Dallas-Fort Worth, TX, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2023 — Present

Post Market Quality Specialist @Artivion, Inc.

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Kennesaw, GA, US

Post Market Surveillance SME- Acting SME for PMS team reviewing CEP, CER, SSCP, PMCFP, and PMCFRs- Drafting all PMS Plans/(PSUR) Periodic Safety Update Reports- Leading/Presenting for PMS Quarterly Data Review with cross-functional teams- PMS SOPs, templates, and Work Instructions author- Quarterly PMS Data Reports by Product group (Complaints, Customer Feedback, Similar Device Review, CAPA review, FSCA review, IMDRF rates)Complaints SME- Support team as SME on complaint process- Risk Review for complaints- Monthly Trending (Using statistical analysis and drafting report)- Monthly KPI data (Complaints, Post Market Surveillance, Recalls, HRAs)- Data requests for Post Market Surveillance from around the world.Customer Feedback-Quarterly Customer Feedback Reports-Lead cross-functional review and present data with stakeholders

EDUCATION

1997 — 1998

USMC Communications and Electronics School

Certification, Electronics, Radio Repair

SKILLS

ValidationProduct ComplaintsStrategic PlanningTechnical SupportComplaint HandlingQualityProblem SolvingDocumentationIso 13485Business Process ImprovementFdaTeam BuildingManagementCross-Functional Team LeadershipTechnical ServiceQuality AssuranceComplaint ManagementPublic SpeakingQuality AuditingTrainingAuditingGmpForecastingContinuous ImprovementSales OperationsInvestigationCustomer ServiceHealthcareConsultingProcess ImprovementQuality SystemLeadershipU.s. Food and Drug Administration (Fda)Complaint InvestigationsManufacturingCapital EquipmentSalesProject ManagementCommunicationMedical Devices

ABOUT DEVIN STABILE

Artivion empowers post-market quality initiatives with a dedicated focus on surveillance, complaints, and customer feedback systems. With over two years in the current role, contributions include drafting PMS plans, authoring quarterly data reports, and leading cross-functional reviews to maintain compliance and safety standards. Expertise spans SOP creation, risk assessment, and metrics-driven reporting to support critical regulatory needs. Previous roles at Apple and OsteoMed enhanced process improvement, complaint investigations, and regulatory reporting capabilities. A commitment to improving post-market practices ensures alignment with evolving industry standards.

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