SUMMARY:

Engineering Professional with more than 5 years of experience in Medical Device Industry, with in depth knowledge and strong base in Design Controls, Manufacturing, Quality Engineering, Product Line Transfer and Implementation, Process Validation, Test method validation & Equipment Qualification. Well - versed with applying the manufacturing quality toolset including PFMEA, Control plans, GR&R / MSA, GD&T, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC. Knowledge of new product development: Design Controls, Quality Planning, compliance including DHF/IDF, Verification and Validation, Risk Management, Process Validation (IQ/OQ/PQ) protocols and reports.

TECHNICAL SKILLS:

LeanManufacturing, Continuous Improvement, Control Plans, Gage R&R, Risk Management, Six Sigma, Lean Manufacturing, Minitab, ProcessImprovement, Continuous Improvement, Assembly, SPC,ProcessValidation, Risk Management, NCMR, SCAR, Process& Test Method Validations, Process Mapping, FMEA, Quality Control Plans, CAPA, Root Cause Analysis, Statistics, Quality Audits, SPC, new product development, CAPA, IQ, OQ and PQ in regulated environment & FDA compliance.

Statistical and Design tools: JMP, Minitab, Solid Works, Creo,Hypermesh,MS Visio and Draft Sight.

PROFESSIONAL EXPERIENCE:

Confidential, Ann Arbor, MI

Manufacturing Quality Engineer

Responsibilities:

• Work with Production, Manufacturing/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes.
• 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)
• Responsible for maintaining Quality System Regulations (Part 820) and Regulatory Standards (ISO 13485/14971 )
• Ensured risk assessments are thorough and deliverables meet all governing requirements.
• Performed protocols documentation for the cleaning equipment of manufacturing and packaging area.
• Performed validation report for the cleaning equipment of manufacturing and packaging area.
• Risk Management: FMEA and fault tree analysis
• Support and perform Quality Audits - Internal, External, FDA, BSI Regulatory Bodies
• Statistical inspection sampling plans
• 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
• Involved in Engineering Trial like temporary deviations in sending parts to customers before PPAP
• 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.
• Disposition non-conforming material requiring advanced process/technical knowledge. Work directly with suppliers to prevent or correct discrepant material
• 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.
• Product Impact Assessments: Analyze and rationalizeCAPAs, Nonconformance (NCs) & Observations, Failure Investigations and root cause analysis.
• Created Change Control andDHFRemediation processes using Lean Methodologies (Kaizens, A3s, and Standard Work).
• Authored DHF requirement documents, verification & validation plans/reports, functional verification protocols and reports, DFMEAs, and other risk documentation for multiple design change projects. develop a multi-level DHF architecture to help ensure compliance with procedures and regulations to sustain product DHFs.
• Traced verification and validation data to design inputs within the DHF architecture.
• Participated in Design History File (DHF) Remediationas a Quality Engineer and Verified the quality and completeness ofDHFdocuments including DFMEAs and research reports
• Comprehensive understanding of Design History File (DHF) and associated remediation activities.
• Involved in developing all design controlriskmanagement documents such as plans, hazard analyses, and design and process FMEA's, and reports.

Confidential, Murray Hill, NJ

Project Engineer - Manufacturing

Responsibilities:

• Responsible for all aspects ofQualityAssuranceactivities for manufacturing and engineering on multiple programs
• Participated in the development and maintenance of PFMECA, PQP, QRD, Corrective Action / Preventive Action, First Articles,inspectionplans, checklists, and SOPs
• Develop Technical Studies, Risk Analysis, Process Mapping, DOE’s, Gap Analysis, Statistical Rationales, Discrepancy Reports, among otherdocumentation.
• Responsible for Customer Complaint Investigations, CAPA projects, Cost Reduction and Continuous Improvement projects,QualitySystems Excellence among other projects.
• Experience conductingaudits, risk analysis, risk assessments, PFMEA, DFMEA to corporatequality systems.
• Performed Risk Analysis and FMEA and initiate SPC for product and process success
• Assists in investigations associated with Out-of-specification (OOS) and Non-conforming material reports (NCMR), Deviations,CAPA, Supplier Corrective Action Reports (SCARs)
• Responsible for implementing and maintainingsupplierqualification/ disqualification,supplier monitoring, product validation, and process validation
• Responsible for first articleinspection, incoming and in processinspections and lot release testing, including sampling strategies and test methods
• Evaluated product and process performance such as, pareto charts, statistical process controls, and process maps.
• Developed and approved quality system documentation such as operations procedures and work instructions.
• Worked with Manufacturing Engineers in developing process validation protocols, FMEAs, quality plans, manufacturing procedures, inspection plans, and specifications.
• 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
• 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 Quality Audits - Internal, External, FDA, BSI Regulatory Bodies
• Ordering & Purchasing for Production, Quality Control and R&D teams; performed quarterly inventory for Production team, point of contact for vendor representatives
• Statistical inspection sampling plans
• Product Impact Assessments: Analyze and rationalizeCAPAs, Nonconformance (NCs) & Observations, Failure Investigations and root cause analysis