SUMMARY

• Over all 7 Years of Professional experience as a Quality Engineer in a medical device industry with a strong emphasis on quality and process improvements.
• Direct hands on leadership with strong quality system acumen in post market surveillance/product failure analysis, Suppler Quality, DHF/FMEA assessment & Remediation Projects, Risk Management, CAPA/NCR, process improvement, complaint handling/MDR, and MDD/AIMDD.
• Expertise knowledge in Quality and product design with a strong emphasis on quality and process improvements.
• Hands on experience as a Quality Engineer for a medical device company launching a new class III medical device with a focus on injection molded components.
• Expertise in medical device and FDA regulations, Advanced engineering tools including GD&T, Failure Modes Effect Analysis (FMEA), FTA and Root Cause Analysis.
• Worked in Medical devices, Electro mechanical product development life cycle involving Concept design, Testing, Process validation, Qualification, and Commercialization.
• Hands on experience in transfer new product to Quality and Process improvement, Equipment Validationand Qualification (IQ/IQ/PQ) and process validation in clean room environment,
• Expert proficiency in all areas of primary production Quality of medical devices and many other products.
• Expertise experience with medical device manufacturing lines set up and transfer, design to Quality transfer, research and product development, quality management systems, design control, FDA, GMP, EU, ISO13485, regulations, project management, lean Quality, process improvement and validation IQ/OQ/PQ, ECO, FMEA, risk, failure, root cause analysis, biocompatibility, sterilization, shelf life, CAPA/ NCMR investigations, 510K.
• Expertise in design and Quality of class II and III surgical, orthopedic, implantable prosthetic, interventional and disposable medical devices such as catheters.
• Hands on experience with injection molding and extrusion, material selection, procurement of new equipment, setup and production scale up, automation, CIP projects, mold, fixture, tooling design, Gauge R&R, process validation, inspection criteria, Bill of Materials, CAD 2D and 3D, Geometric dimensioning.
• Outstanding track record in process development and sustainability, facility management, capital expansion, validation programs, compliance and Quality cost reduction.
• Well versed with ETQ, PDM, Software validation, MS Excel, Word, Visio & Project, Solid works, Uni - graphics AUTOCAD, Catia.
• Expertise in Wind chill, Intralink, cPDM, JDE, SAP, Minitab, Stat graphics, Agile, Track Wise, ADAPTIV, PDM.
• Experience in Solid Works, Pro-E; 2D and 3D modeling experience, and also experienced in simulation software ANSYS. Knowledge and experience working in GMP (Good Manufacturing Practices) and GDP (Good Document Practices).
• Working knowledge of statistical tools and methodology DOE, ANOVA, SPC, regression, Lean, DMAIC, Six Sigma, DFX, Kaizen, project management tools and methodology.
• Experienced with measurement and testing equipment and tools like CMM, Keyence, Smartscope, Optiv, Instron, Lloyd.

PROFESSIONAL EXPERIENCE

Confidential - Chicago, IL

Quality Engineer

Responsibilities:

• Team leadertasked to implement the specific components for Confidential .
• NPI process validation of investment casted CNC machined class III medical devices.
• NPI process validation of laser marking equipment for class III medical devices (IQ, OQ, PQ).
• Lead Quality engineer supporting the finishing department of Class III surgical implant, instrument, and case Quality in a FDA regulated environment.
• Independently designed and manufactured a spring force measurement fixture to perform a Gage R&R on CTQs of a component.
• Lead to remediation activities for knee reconstruction and major gaps analysis for existing products.
• Implemented process improvements and cost reduction practices including the installation of a 6-axis robot into a hazardous nylon bath Quality cell. Developed cost savings and manpower re-assignment plan to avoid reduction of work force.
• Experience with installation and programming of CNC,6-axis and SCARA robots. NCR and CAPA control, SOP creation.
• Lead multiple Kaizen and six sigma events in different areas of the plant.
• Redesign Quality floor layouts to optimize flow (one piece flow), reduce WIP, improve safety and ergonomics, and optimize floor space
• Internalize operations to reduce WIP, reduce Lead Time, and reduce operator idle time.
• Updated and improved Quality processes to improve standard work, quality, and output.
• Coordinated the Kaizen Suggestion System used to gather and implement improvement ideas.
• Worked with a team to correct documents that were transferred from Agile to ADAPTIV.

Confidential, Minnesota, MN

Quality Engineer

Responsibilities:

• Managed all complaints for Disposables Product Families by performing detailed product analysis and conducting individual investigations on high level complaints files.
• Ability to setup, run, program all machines in csp area. CNC Programming prototypes plates.
• Performed FEA on an internal plastic component to assist a CAPA root cause investigation, resulting in a design change and elimination of the leading failure mode
• Supported the production line for Plastic Injection Molding, Raw Material team and worked with cross-functional teams.Wrote and delivered technical documentation, drawing and design improvements, design verification and validation reports, process validation (IQ/OQ/PQ) reports, tooling, fixtures and mold design.
• Performed mechanical design and revision of Quality equipment, tools, and fixtures using Pro-E and SolidWorks.
• Designed the test fixture to detect intermittent connection in Percutaneous Lead and performed test method validation (TMV).
• Wrote test scripts & deliverables for validating Documentum Version. Wrote SOPs / working practices for different departments.
• Reviewed documents for Process Validation (IQ, OQ, PQ), Master Validation Plans, Test Method Validation (Gage R&R), Process FMEAs.
• Perform detailinvestigation to determine most likely root cause and further escalation of individual complaint.Extensively worked on Product Development Process: NPD and Sustaining. DHF, FMEA, FMECA, Verification, Validation, Launch.
• Updated and developed Risk Management Reports and assessed risk and occurrence ratings for individualcomplaint file.

Confidential, Bloomington, IN

Quality Engineer

Responsibilities:

• Field of experience: Project management, MRI RF coils, Electro-Mechanical Packaging, Injection Molding, Sheet metal, Reliability practices, Regulatory & NRTL (MDD, UL, ETL, IEC, FDA), Agile. ATE fixture design for spine.
• Developed and prototyped lightning fixtures creating multi-configuration SolidWorks assembly; directly cooperating with customers and fulfilling client's requests.
• Performed CAPA (Corrective Action and Preventive Action) as well as overseen all aspects of the NCM (Non-Conforming Material).
• Created Process Validation Plans, Process Maps, Process Requirements, pFMEA, protocols and reports for IQ, OQ, PQ, and MVP's as part of remediation.
• Responsible for development and execution of Qualification Protocols (IQ/OQ/PQ) and writing reports.
• Supported volume ramp up by ensuring adequate tools, fixtures procurement and by conducting capacity planning
• Engineering change, Documentation for Electrical and Mechanical components BOM creation, applying GD&T, ANSI, ASMEY14.5. Strong SAP, Lean Quality, 6 S experience.
• Supported in SOPs writing, CAPA, OOS Investigation, root cause analysis.
• Reviewed Test Method Validation (TMV) for all functional and interface test methods for Disposable products. Performed test method validations (Gauge R&R studies - Minitab).
• Performed Quality review for validation lifecycle documentation for various medical device product families, including: Master Validation Plan, Formal Test Plan, DOE, Process Validation, Test Method Validation, Installation/Operational/Performance Qualifications, and Summary Reports.