Amol Parkar

About Amol Parkar

25+ years experience in the medical device industry. Strong background in plastic materials/processing, sterilization validation, hydrophilic coating, FMEA, validation (IQ, OQ/PQ) and statistics. 6 sigma green belt certified.ASQ certification - CMQ/OEManufacturing Engineering: pFMEA, work instructions, process capability, inspection protocolsProcess Development (DOE)Validation (IQ/OQ/PQ)Project Management6-Sigma Green BeltTransfer Products from R&D to Manufacturing & transfers to low cost mfg sitePlastic materials (selection, processing & analysis)Hydrophilic coating of cathetersEO sterilization of medical devices (validation & re-qualification)/Gamma sterilizationThermal bonding, UV bondingRisk AnalysisNCRs, Failure investigations, Root cause identification, CAPAsLabeling: UDISQA:Supplier selection.Supplier development: Component assessment & data correlation.Certified ISO 13485 Lead AuditorOperations Quality:IQCNCMRs, CAPAs, Planned DeviationValidation support; Data analysis using MinitabCER qualification; Environmental Monitoring; Quarterly Dose Audits (Gamma Sterilization), LALFixture/equipment QualificationChange Assessment/ControlInternal Audits/Notified Body Audit SupportMentoring of junior engineers

Experience

1. Principal Quality Assurance Engineer

   Calyxo, Inc.

   Mar 2023 — Present · Pleasanton, CA, US

   A strong understanding of Medical Device Quality concepts per ISO13485 & FDA 21CFR820.Support production of CVAC devices - IQC support, NCMRs, CAPA, LHR Review, Label Inspections- CER Environmental Monitoring, Bioburden- Equipment QualificationsAssist in Process DevelopmentQuality System ImprovementsAssist in Process Validations - Protocol development, Sample size justificationSupplier audits

Education

• Pune University

  B. E., Polymer

  1987 — 1991

• University of Warwick - Warwick Business School

  Master of Business Administration (MBA), Operations

  2008 — 2012

• University of Massachusetts Lowell

  M.S., Plastics Engineering

  1991 — 1993

Skills

• Fda
• Continuous Improvement
• Spc
• Biomedical Engineering
• Minitab
• U.s. Food and Drug Administration (Fda)
• Certified Iso 13485 Lead Auditor
• Design Control
• Fmea
• Process Capability
• Pfmea
• Design of Experiments
• Manufacturing
• Corrective and Preventive Action (Capa)
• Quality System
• V&V
• Iso 13485
• Cross-Functional Team Leadership
• Supplier Quality
• Root Cause Analysis
• Plastics
• Validation
• Medical Devices
• Capa
• Verification and Validation (V&V)
• Statistical Process Control (Spc)
• Supplier Development
• Failure Mode and Effects Analysis (Fmea)
• Process Improvement
• Project Management
• Non-Conforming
• Troubleshooting
• Injection Molding
• Six Sigma
• Dmaic
• Manufacturing Engineering