Products include: Orthopedic ImplantsAccomplishments:• Worked with teams to perform Corrective and Preventive Action (CAPA) investigations, determined scope of non-conformance, found Root Causes, selected and implemented Corrective Actions, and evaluated Effectiveness Monitoring (EM) of final resolutions.• Drafted Spreadsheet Validation Protocols.• Created Master Process Control Plans for line extensions.• Designed and procured measurement systems for implantable medical devices.• Evaluated product and process non-conformance, analyzed end-user risk in relation to corrective actions.

Products include: Thrombectomy Systems, Ablation Equipment, Access Devices, CathetersAccomplishments:• Performed Design History File (DHF) remediation in compliance with EU MDR• Created Design Control Traceability Matrices (DCTM) linking design inputs, hazards, risks, and risk controls with Design Verification and Design Validation• Reviewed Complaint History Files (CHF), linked complaints to hazards and harms

Products Include: Orthopedic Implants and Instruments.Assisted with assembly, review, and submission of US 510(k) and EU Design Dossier.Developed supplier Master Validation Plan (MVP), Installation Qualification Protocol (IQ), Operation Qualification Protocol (OQ), and Production Qualification Protocol (PQ)Created design concepts for measurement systems.Reviewed and revised Design Verification and Design Validation Protocols.Evaluated and approved Test Method Validations.Reviewed prints for proper application of GD&T.

Products Include: Catheters, Micro-catheters, Introducers, Stents, Drains, Wire Guides, and Dilators.Achievements:• Performed review of Design History File (DHF) documents• Assisted with DHF remediation

Products include: Automated External Defibrillators (AED)Achievements:• Assisted with corporate wide Quality Transformation• Performed ISO Audit Readiness and FDA Investigation Readiness• Evaluated Supplier Monitoring Process for compliance and effectiveness

Products include: Tracheostomy TubesAchievements:• Created Master Validation Plans (MVP)• Performed risk management for manufacturing processes• Implemented Design Input and Design Output tracking system• Developed work instructions for inspection processes• Performed and evaluated process capability studies including Pp and Ppk indices• Determined and documented product acceptance criteriac

Products include: Orthopedic Implants and InstrumentsAchievements:• Performed Supplier Production Process Acceptance (SPPA) for sourced product• Provided guidance and coached suppliers in areas of deficiency or uncertainty• Assisted suppliers in their drafting of process validation protocols• Reviewed and approved supplier process validations including IQ, OQ, and PQ• Facilitated Test Method Validations (TMV) and Measurement System Analysis (MSA)• Reviewed concepts through product design and development phases to ensure ability to be efficiently manufactured and effectively measured• As part of Design Transfer Process, reviewed and approved Process Control Plans and Measurement Systems• Developed and updated Inspection Instruction Sheets (IIS) for use in receiving inspection• Trained and advised Quality Engineers on validation concepts, requirements, and techniques

Products include: Thoracic Drains and Vascular GraftsAchievements:• Remediated Design History Files (DHF) as part of Corrective and Preventive Action (CAPA)• Evaluated and improved component and assembly prints and specifications• Updated Design Failure Mode Effect and Criticality Analysis (DFMECA) records• Reviewed ability to inspect products and modified inspection check sheets• Performed design review to assure product manufacturability

Products include: Orthopedic ImplantsAchievements:• Remediated risk management documentation in compliance with ISO 14971:2012• Implemented portion of Global Remediation Quality Plan (GRQP)• Supported operations as QA Risk Management SME

• Assisted in making improvements to Measurement Instruction Sheets (MIS) and work instructions which provided 72% reduction in documentation errors as measured at Device History Record (DHR) final review• Rationalized and reduced inspection required within profit center by 35 % overall and by up to 67% on specific product lines• Lead Quality Engineer supporting manufacturing of hip stems in eight (8) profit centers with 158 production associates• Performed Quality Investigations and submitted Quality Investigation Reports (QIR) on time while achieving 100% CAPA review committee acceptance rate• Facilitated development and execution of Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) per 21 CFR 820.75• Member of Validation Core Teams for nitride, diffusion bond, high-energy plasma spray (HA/TCP), laser cutting, and final clean processes• Quality Subject Mater Expert (SME) supporting heat-treat processes in three (3) profit centers• Participated in internal quality system audit to verify compliance with 21 CFR Part 820 and ISO 13485 per ISO 19011• Trained and certified production operators on the use of measurement equipment, interpretation of drawing requirements, Good Documentation Practices (GDP), and requirements of Standard Operating Procedures (SOP)• Created and maintained Quality Operating System (QOS) charts posted within production departments• Performed risk assessment in support of CE Mark renewal process as required by European Directives• Reviewed production drawings for proper application of tolerances (per ASME Y14.5M) and ability of product to be measured• Guided response to ANVISA regarding questions about compliance with ISO 7206-2

• Updated and documented requirements for suppliers and coordinated development of prototype suppliers reducing incoming defects by over 50% within two months• Created ISO 9001 and ISO/TS 16949 compliant Standard Operating Procedures, developed training materials and trained all affected employees• As Lead Auditor, verified effectiveness of the Quality Management System and tracked resolution and verification of corrective actions for audit findings• First to submit and receive PPAP approval of US made automotive lithium ion battery pack assembly for plug-in electric vehicle• For customer quality concerns, determined root cause, implemented corrective actions, documented results, and submitted corrective action reports to customers• Assisted production operators, manufacturing engineers, and supplier quality in the resolution of production quality concerns• Developed Early Production Containment (EPC) process, created associated check sheets, trained personnel, and evaluated inspection results for application of process improvements• As member of design review team, verified that prints clearly communicated requirements with proper application of dimensions and tolerances (GD&T), that components could be manufactured, and that product could be assembled and tested• Participated in and coordinated Advance Product Quality Planning (APQP) including use of DFMEA, PFMEA, Process Flow Diagram, Control Plans, Design Verification Plan and Report (DVP&R), Measurement System Analysis, Process Capability Studies, Production Part Approval Process (PPAP), and Part Submission Warrant (PSW)