SUMMARY

• Applied knowledge of statistical process control (SPC), Lean Manufacturing / Six Sigma, failure modes and effects analysis (FMEA),designfor manufacturability (DFM), DOE analysis, root cause FA/FDA hazard & risk analysis, geometric dimensioning and tolerancing (GD&T), short and long term gage capability.
• Excellent understanding of FDA regulatory obligations and compliance within the scope of 21 CFR part 820.198, part 820.200, part 820.100, part 820.90 and part 820.22)
• Conduct new product development to meet the expectations of international standard, ISO 13485, Quality Systems, Medical Devices, System Requirements for Regulatory Purposes and the FDA21 CFR 820, Quality System Regulation.
• Follow and control incoming inspection verify the data recording fully capability to detect the defect parts. Follow up and completed First Article Inspection report fromsupplier.
• Analytical and precise, creating and validating new manufacturing andqualityprocesses.
• Extensive experience in Risk Assessment, Design Verification/Validation, quality planning and compliance, test methods validation and product development process in medical device industry.
• Excellent problem solving skills, project management skills and ability to work independently. Expertise in writing DFMEA and PFMEA for new product and conducting team reviews to evaluate risk.
• Extensive knowledge on newproductdocumentation includingproductrequirements, test protocols and reports, and risk analyses to develop a complete DHF and DMR files by employing ISO 13485 standards and FDA Quality System Regulations.

TECHNICAL SKILLS

• DesignControl
• MedicalDevices
• Laboratory Operations
• QMS Auditing
• Technical Writing
• Lean Manufacturing Operations
• Process Improvement
• LeanQualityTools (FMEA
• Pareto Charts
• Fishbone Diagrams
• Six Sigma
• 5S
• Control Charts
• Process Mapping
• Kaizen)
• QualityAssurance
• Change Management
• Six Sigma Program Planning
• Process/Performance Monitoring
• Project Management
• Strategic Planning
• Operational Redesign
• Verification/Validation
• Risk Management
• Complaint Management
• Crisis Management
• FDA and ISO regulations
• Regulatory Compliance
• New Product Development

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential, Irving

Responsibilities:

• Participated in specified system customer audits as well as the processes affecting the product design.
• Control the processes and products qualities for design projects.
• Ensured all inspection/testing equipment are controlled and calibrated.
• Supported Non - conforming material investigation and disposition (NCMR).
• Worked with customers on quality issues for continuous improvement, perform internal/external corrective and preventive actions as required, and compile monthly reports for preventive actions
• Supported internal audits and ensure that issues raised form the audit is resolved satisfactorily.
• Supported training activities.
• Experienced in in statistical data analysis using Minitab (Gage R&R, Anova studies). Led in development and execute Test Method Validations (TMVs), develop, execute, review and approve Validation protocols (IQ, OQ, and PQ) and reports
• License administration and provided support for builds and related documentation on projects.
• Support vendor activities, monitor their performance, recommend and initiate continuous improvement measures.
• Generate quality procedures, instructions, checklists, control plans and quality related documents, and ensure that they are followed accordingly and guiding in the interpretation of the quality/design and development plan
• Involved with design, quality and operation teams to identify and mitigate risk associated with hazards through Process FMEA
• Maintained DHF and updated it at end of every phase; Maintained document deliverables list and update it periodically
• Review project deliverables (documents, parts, ECOs)
• Ensured PLC gate reviews are performed correctly per each phase
• Ensured design reviews (DIR, TRR, DOR, DTR) and technical reviews (EE schematic review, layout review, ME models review, drawings review, SW design reviews PER BUILD) are performed correctly per each phase and reports released and action items tracked.
• Ensured build readiness reviews are performed correctly for each Feasibility(fx), Characterization(Cx), and DV builds
• Led multiple Life Cycle Engineering projects, conducted system level requirement analysis, worked closely with the Systems Engineers, RA, QA technicians focusing on Standard Operating Procedures (SOPs), IQ/OQ/PQ activities, test method validation and CAPA for effective workflow planning, execution and successful completion of verification activities of the project
• Verified project members are trained correctly on QMS, project specific documents (V&V plan, build protocol etc.) and training records maintained
• Approve suppliers for custom and critical components via QMS procedures
• Hold CCB meetings once project enters formal change control
• Periodically review issues tracking database and verify issues are being resolved and closed.
• Periodically review Risk management file (FMEA, RMP etc.)
• Periodically review customer property log and verify that items are logged correctly and get any equipment calibrated as needed

Quality Engineer

Confidential, Englewood, CO

Responsibilities:

• Employed statistical tools to track process capability and determine root cause of deviations from specification to implement process improvements.
• Managed all phases of thedesignprocess for the Mud Lift Pump project,components, parts, assemblies and subassemblies, including drafting,dimensioning,tolerancing, and documenting results. Known for quality excellence and a "do-it-right-the-first-time"designpractice.
• Ensured the customercomplaintinvestigation, procedures, and activities comply with applicable FDA and ISO requirements forcomplainthandling and adverse event reporting.
• Implemented reports to manage and prioritizecomplaintinvestigations
• Led, facilitated, assigned, completed and verified completion of productcomplaintinvestigations and tasks to closure for self and cross-functional teams to ensure timely completion ofcomplaintinvestigations
• Planned and executedcleaningand packaging validations includingsterilizationand distribution testing
• Provided and analyzed trending information necessary for quality monitoring and assessed the impact to products.
• Designed and implemented manufacturing fixtures to control quality of manufactured product, resulting in decreased product non-conformances on the floor
• Led investigations of non-conforming products / processes to determine root cause, containment anddesign impact. Compiled technical reports in support of NCMR investigations, CAPAs and containment activities used to supportqualitydecisions and responded to FDA 483 inspection observations.
• Led all productdesignrelated corrective and preventive actions (CAPAs). Ensured that CAPAs are completed in timely manner with root causes investigations and supported corrective actions that are commensurate to the risk of issue being corrected.
• Provided technical support to R&D, manufacturing engineering, regulatory affairs, supply chain, and qualityto ensure conformance to component/product specifications.
• Handled process related non conformances such as periodic calibration, preventive maintenance and equipment parameters.
• Managed low risk Nonconforming Product Reports (NCR’s) per the decisions made at the MRB meetings.
• Led Risk Management (U/DFMEA) workbook development while coordinating with R&D, PD, Clinical, Marketing, Packaging and Regulatory teams.
• Completedqualityactivities for design changes and new product, provided design inputs.
• Served on new product development teams to ensurequality, reliability, manufacturability, serviceability, regulatory compliance and fulfillment of customer expectations.
• Prepared or revised Risk Management Plans, Risk Management Reports, Hazard Analysis Reports, DesignFMEAs and Use FMEAs. Maintained Risk Management File in the electronicDesignHistory File (DHF).
• Performed GAP Analysis of existing RM Plans and suggested Remediation activities.
• Implemented and managed Design History File (DHF), Functional design requirements, design input and output (I/O), design Verification and Validation (V&V), and design risk management analysis.
• Wrote and executeddesignverifications, validations, test methods, control plans, and other related documentation fordesignprocess transfers.
• Facilitated risk analysis meetings to determine failure modes, failure effects, severity, failure causes, probabilities of occurrence, RPN numbers, risk mitigations, implementation of risk control measures, residual risk evaluation, and risk/benefit analysis.
• Developed and executed Test Method Validation (TMV) protocols. Performed Gage R&R studies. Prepared TMV reports.
• MaintainedDesignHistory File (DHF) to ensure its full procedural and regulatory compliance and readiness for audits.
• Provided design assurance quality support for new product development as a core team member. Ensured design controls are followed during all stages of PDP.
• Assisted local and international suppliers with test method validations (TMV), process validations, process FMEAs, and process capability studies.
• Analyzed data, metrics, and trends for keyqualityperformance indicators as needed.
• Performed document review and Gap Analysis for ensuring compliance to QMS and QSR.
• Wrote equipment qualification protocols and reports (IQ and OQ).
• Performed QA review of characterization and process validation documents. Utilized Minitab (ANOVA and process capability tools) to determine if processes met requirements.
• Used GD&T to interpret designs, blueprints and engineering drawings.
• Conducted Reproducibility and repeatability studies on the part-to-part variation & analyst-to-analyst using Minitab.

Quality Engineer

Confidential, Parsippany, NJ

Responsibilities:

• Led Internal and external audits to monitor client's quality management system or specific processes for products per the annual audit schedule or as indicated by performance monitoring triggers
• Supplier quality control and development. Supplier election and qualification, supplier resources integration, technical support, supplier performance evaluation and improvement, non-conformances identification and initiation, process and product audits
• Approved and implemented the customers' product design drawings; investigated and analyzed field returned products; managed the complaints and customer support; implemented corrective actions (CAPA).
• Evaluated and completed non-conformance reports, product complaints, CAPA’s and field actions and analyzed if they should be escalated to a CAPA.
• Assisted with the investigation of Corrective/Preventive Actions (CAPA) to determine the root cause using fishbone diagram, 5Whys, etc.
• Reported trends in Deviation and CAPA records to monitor performance for continuous improvement.
• Identified and created trend analysis for key quality performance indicators and NC/CAPA effectiveness monitoring
• Implemented disposition of discrepant material (MRB) managed recalls and devised methods to assess cost and responsibility.
• Developed Inspection Method and Test Method Validation (IMV/ TMV) Protocols and Reports
• Completed test method and process validations (TMVs) for new instrumentation, raw material properties and component qualifications.
• Developed and maintained Requirement Traceability Matrix (RTM) to cross-reference the functionality to the required test cases and scripts.
• Conducted Risk Assessment, Risk Management plan, DFMEA, Hazard Analysis, and Risk Management reports.
• Participated in risk identification and assessment (FMEA) actions for new/changed equipment and processes.
• Collaborated with cross functional teams to facilitate Risk Management activities such asDesignFMEA, Process FMEA and Risk Analysis.
• Developeddesigndocumentations, to include DFMEA, PFMEA. Developed and wroteDesign qualification plans and reports, and executed thedesignverification plan.
• Recommended alterations to development and design to improve quality of products and procedures.
• Created design verification protocols/reports and test method to ensure each claim has supporting evidence in the DHF.
• Gathered source documents for DHF and created Design Trace Matrix (DTM). Authored protocols and reports where necessary to complete the DHF.
• Leddesignassurance anddesigntransferactivities for New Product Development.
• Developed and reviewed documents for Process Validation (IQ, OQ, PQ), Master Validation Plans, Test Method Validation (Gage R&R), Process FMECAs.
• Appliedqualityengineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE, MSA and Control Plans.
• Supported remediation of theDesignHistory File that includes Customer Requirements, Product Requirements, System Level Requirements, Hazard Analysis,DesignFMEA and Process FMEA
• Utilized statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability.
• DevelopedQualityPlans including acceptance activities for incoming, in-process and final inspection.
• Created newSupplierQualityMetrics to identify and target poor performingsuppliers and issued corrective actions.
• Developedsupplierqualitymetrics to meet the requirements of theQualityManagement Review.
• Was Responsible for supplier qualification and management of all suppliers across all programs.
• Applied knowledge of GD&T and tolerance stacking to ensure high precision gages meet design criteria
• Conducted design of experiments (DOE) to identify critical variables in a process and established design limitations.
• Successfully developed, maintained and updated Standard Operating Procedures (SOPs), Design History Files (DHF) and Design of Experiments (DOE).