Marlon Pineda

Quality Assurance Manager @SHL Medical

Deerfield Beach, FL, US

Directly oversee a team of QA Engineers and QA Specialists that performs different quality assurance functions.• Work closely with cross-functional teams of diverse departments like QA Systems, QC, Product Development (PD), Analytical Sciences (AS), Manufacturing Sciences (MS), Manufacturing Engineering (ME), Manufacturing, Packaging, Supply Chain (SC), Regulatory Affairs (RA), Project Management, Facilities, EHS in different projects.• Perform final review and approval of commercial and clinical batch records, and product validation batch records and Engineering Protocols (ENP).• Review and approval of COA/COC. • Perform product release of finished products in SAP.• Review and approve Design Transfer Plan (DTP), Design Transfer Report (DTR), Validation Process Plan (VPP), Validation Process Report (PVR), Test Method Development (TMD), Test Method Validation Plan (TMVP), Test Method Validation Report (TMVR), Technical Specifications (TS), Product Specifications (PS), Bill of Materials (BOM), Batch Records (BR), Process Qualification (PQ), Process Validation (PV), Process Validation Plan (PVP), Process Validation Report (PVR), Stability Protocols (STP), and Stability Report (STR). • Review and approve Equipment IOQ, PQ, Factory Acceptance Test (FAT).• Review and approve Risk Management Plan (RMP), RMR, pFMEA, Risk Assessment and Controls (RAC).• Review and approve Test Method Development (TMD), Test Method Validation (TMV), Test Method Transfer (TMT).• Review and approve Change Controls, Standard Operating Procedures (SOPs), Working Instructions (WIs), Engineering Change Order (ECO), Engineering Protocol (ENP).• Perform, Support, Review and Approve Non-Conformance Investigations, CAPAs, VOE, DOE, OOS, SCAR and Deviations.• Perform, support and participate in Regulatory Authorities, customer and internal audits. • Contributed in the successful launch of CMO products in the US and EU markets.• Participated in different Continuous Improvement projects.

ASQ

Engineer's Degree, Certificate of Quality Engineer

Harrington Institute Inc.

Certificate, Lean Six Sigma Green Belt

Florida International University

Certificate, Brazilian Studies

Florida International University

BA, International Relations

Florida International University

Certificate, Latin American and Caribbean Studies

Miami Dade College

A.A, International Affairs

Nova Southeastern University

Master, Business Administration

Walden University

Ph.D, Applied Management and Decision Sciences; Leadership and Organizational Change

Acuity Institute

Certificate, Six Sigma Black Belt