SUMMARY:

• Experienced Manufacturing/Quality Engineer in medical device industry with responsibilities involving quality and technical liaison between engineering, internal and supplier manufacturing operations in support of the product life cycle.
• Supported design transfer, design / process validation and helping to establish/track quality metrics, evaluation of new and modified product designs for quality characteristics, including manufacturability, serviceability, and conformance to product requirements.
• Strong Knowledge about the Confidential regulations, 21 CFR part 820, Part 11 and ISO 14971, 13485.
• Expertise in risk based sampling and data analysis using Minitab.
• Performed PPAP, APQP, First Article Inspection (FAIR) and Incoming Inspections.
• Evaluated the process Repeatability and Stability and conducted Gage R&R studies.
• Experienced in implementation of Change Management/Control.
• Experienced in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting their mediation plans to mitigate the non - compliance.
• Good knowledge in Lifecycle development forCSV(IQ, OQ, PQ) and SDLC processes.

TECHNICAL SKILLS:

LeanManufacturing, Continuous Improvement, SPC, Six Sigma, GD&T, Machining, Inspection, advance technology, tool & fixture design, new product development, CAPA, IQ, OQ and PQ in regulated environment & FDA compliance

PROFESSIONAL EXPERIENCE:

Confidential, Warsaw, IN

Quality Engineer

Responsibilities:

• Experience with Confidential Good Manufacturing Practices, ISO 9001, ISO 13485, 21 CFR Part 820 FDA's guidance on Validations, Design, Risk Management and other applicable standards.
• Responsible for executing Validation strategy (IQ/OQ/PQ), Design Verification/Design Reviews (DV/DR), coordinate Design History File Reviews (DHF), Device History Records (DHR).
• Responsible for remediating Design History Files for 500 legacy disposable IV products for compliance with internal quality systemprocedures and 21 CFR Part 820.30 quality systems regulations
• Implemented Design History File (DHF)Remediation using Design Control elements as per 21CFR 820.30 Regulations on disposable medical devices.
• Applied in-depth knowledge of productrisk management use standards and tools (e.g. ISO14971:2012, 21CFR820, e.g. SFMA, DFMEA, PFMEA and created required documents
• Developed Design and Process Failure Mode Effects Analysis (DFMEA and PFMEA) to align with the Hazard Analysis Table.
• Performed root cause analysis (RCA) investigations, corrective and preventive action (CAPA) implementations and yield improvement projects
• Performed confirmation studies for potential root causes using various root cause analysis tools such as fishbone diagrams (6M's), 5 Why's, Is/Is Not Analysis, and operator interviews
• Working knowledge of Reliability Engineer Engineering and medical device regulations (FDA 21CFR820, ISO13485), Reviewed documents related to 21 CFR Subpart B Part 4
• Experience in Technical Writing, Online Documentation, Report Generation and Software Documentation.
• Knowledge to review, manage and execute test scripts manually.
• Strong Analytical, Design and Problem-solving skills.
• Mastery and use of software programs - Microsoft Word, PowerPoint, Excel, Outlook, Project, and Minitab.

Confidential, Los Gatos, CA

Manufacturing Quality Engineer

Responsibilities:

• Provide hands-on support and troubleshooting of manufacturing processes, tooling and equipment.
• Analysis and documentation in the management of material, manufacturing process updates, qualification activities, compliance activities, and CAPA's.
• Perform Equipment Installation, Manufacturing Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation for manufacturing equipment and processes.
• Generate all related documentation in compliance with internal and external requirements.
• Support manufacturing facility transfer and product transfer activities to offshore facilities.
• Supplier approvals and the continual evaluation of supplier performance including supplier audits
• Communicate with customers and suppliers on issues related to product quality and performance
• Implement quality and continuous improvement strategies within the quality and manufacturing system
• Troubleshoot equipment and process issues. Summarize and draw conclusions from test results leading to effective technical resolution of process problems.
• Interact with internal and external manufacturing sites regarding product technical complaints, monitors complaint activity for assigned manufacturing sites
• Reviewing and investigating the reported complaints and documenting investigation in results in TrackWise and closing backlog and incoming complaints in compliance with 21CFR820.198.
• Disposition non-conforming material requiring advanced process/technical knowledge. Work directly with suppliers to prevent or correct discrepant material
• Worked with QARA Department to organize internal process for better Root Cause Analysis.
• Established communications and expectations with key suppliers.
• Ran and participated in meetings to bring focus to the importance of supplier interaction and adequate reporting.
• Audited new international suppliers to evaluate capabilities that would be fit for SenDx as alternatives to existing supply base.
• Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.
• Work with Production, Manufacturing/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes.
• Reviewed design histories files (DHF), performed GAP analysis and prepared Remediation Plans to fix the gaps identified
• Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.
• Documentation Control: Engineer Change Order, Create, Review and Approval Specifications, FMEAs, BHRs
• Validations: Development of test methods, process validation (IQ/OQ/PQ)
• Risk Management: FMEA and fault tree analysis
• Support and perform process Audits - Internal, External, FDA, BSI Regulatory Bodies
• Statistical inspection sampling plans
• Product Impact Assessments: Analyze and rationalizeCAPAs, Nonconformance (NCs) & Observations, Failure Investigations and root cause analysis

Confidential, Murray Hill, NJ

Project Engineer - Manufacturing

Responsibilities:

• Responsible for Process FMEA/Production Risk Management Remediation to ensure high level of compliance to Confidential QSR 21 CFR 820, ISO 13485 and ISO 14971 in all assigned areas.
• Responsible for OpenCAPARemediationand Acceleration and Auditing Closed CAPAs assuring products conform to established requirements and standards through appropriate audit, inspection, Process validations and test activities.
• Documented and reviewed operational nonconformance (NCR's), batch impact review and disposition, investigation trending/tracking and commitment tracking/trending for QA.
• Provided input for root cause analysis & problem solving support forCAPA, NCMRs and customer complaints for timely closure.
• Maintained internal Corrective Action Preventative Action (CAPA) System and related documentation (e.g. Non-Conformance, Vendor Defect, Customer Complaints, Internal Citations, etc.)
• Facilitate the investigation process to ensure that CAPA process is timely, identifies the appropriate cause(s) and implements effective action(s) to reduce the occurrence/reoccurrence.
• All the control documents are stored within ETQ under Document control module.
• Requested change using ETQ within document control where document and process owners approve change request.
• Remediated NCR's to determine if NC is complete or needs additional information or affects patient safety.
• Acted as first and second reviewer for assigned NCs, as well as investigator forremediationefforts.
• Was responsible for QA review of complaints to ensure appropriate investigation and risk assessment has been completed with supporting documentation in current complaint database.
• Performed risk evaluation on complaints to determine if they need to be enter into the CAPA System.
• Ensured remediation of existing Risk Management documentation. Performing finding & pulling information from old format Risk Management and reformatting into new Risk Management templates and identifying gaps.
• Performed detailed validation activities to meet customer required, FDA and ISO 11607 medicalpackagingvalidation requirements.
• Executed various DOE’s to establish new or support changing sealing process parameter of the sterile package system.
• Performed a documentation gap analysis for legacy products, as related topackagingand labeling, and executed remediation efforts to ensure compliance to current industry standards
• Used TipQA software to write NC report which includes problem statement, Evaluation, Risk assessment, preventive and containment controls, Bounding and Interim action.

Confidential

Production Engineer

Responsibilities:

• Supported product quality improvement through process development and design changes internally and with suppliers to ensure Manufacturing Engineering deliverables are met.
• Create and review engineering documentation such as BOM, Engineering Specifications, test protocols, technical reports, ECO’s, deviations, and standard work procedures.
• Utilized Problem Solving Processes, Waste Elimination and Standard Work processes to improve sustainable efficiency and quality
• Improved manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout
• Provided engineering support for production and maintenance activities to ensure maximum production
• Investigated problems, analyzed root causes and derived resolutions
• Handled production process and tooling from conventional machines to CNC machines
• Identification, investigation, and correction of non-conformances through CAPA systems
• Authored and executed process validation protocols, activities, and reports, including IQ, OQ, and PQ
• Created of manufacturing work instructions and assembler to the instructions
• Coordination of the transfer activities from device development to device production
• Regular maintenance of process FMEAs
• Utilization of statistical tools, including Gauge Repeatability and Reproducibility studies and Minitab software to analyze data and draw specific conclusions