SUMMARY

• Senior Engineer in Medical device industry with diverse engineering experience including design and development, manufacturing/production, qualification, and validation in Medical Device Industry.
• Extensive experience in Process Validation, Risk Management, Process improvement, Process controls, Continuous Quality improvement and six sigma projects in the medical devices industry.
• Expertise in risk - based sampling and data analysis using Minitab. Performed PPAP, APQP, First Article Inspection (FAI) 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.

TECHNICAL SKILLS

Lean Techniques: JIT, TQM, Kaizen, Kanban, Time Studies, Value Stream Mapping, FMEA, Line Design and Balancing, Continuous improvement

Six Sigma: DMAIC, Hypothesis testing, SPC, 8D, Pareto analysis, Control charts, Process capability studies, Gage R&R

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

Project Management: MS Project, Gantt Charts, Project Scheduling

Analytics: Design of Experiments, Analytical Methods, And Cost Analysis.

Quality: Product reliability and Quality, Project supervision

PROFESSIONAL EXPERIENCE

Confidential

Sr. Quality Engineer

Responsibilities:

• Responsible for new production equipment installation and qualification, process improvements, yield improvements, and cost reductions while supporting daily production activities.
• Collected and analyzed in process data to evaluate capability and determine areas for process improvement.
• Drove process improvements and validations through manufacturing implementation and update PFMEAs and master validation plan as required.
• Provided direct technical support on production issues (e.g. part & assembled product quality dispositions, interim containment actions, root cause analysis, resolution planning, validation, & implementation) under NCMR or CAPA. Provide guidance to other engineers and technicians.
• Improved product quality, labor efficiency, and throughput using Lean manufacturing concepts like Value Stream mapping, 5S and Visual Workplace.
• Worked with cross-functional teams to transfer new products efficiently and effectively into manufacturing.
• Worked with various internal and external organizations to optimize manufacturing processes or resolving technical issues with on-going products or new products.
• Provided technical support to manufacturing and QA to improve productivity and reduce costs.
• Participated as a manufacturing lead and/or support a lead on cross-functional core teams.
• Responsible for implementing and maintaining supplier qualification/disqualification, supplier monitoring, product validation, and process validation.
• Responsible for first article inspection, incoming and in process inspections 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.
• Statistical inspection sampling plans.
• Product Impact Assessments: Analyze and rationalize CAPAs, Nonconformance (NCs) & Observations, Failure Investigations, and root cause analysis.

Confidential

Manufacturing Operations Engineer

Responsibilities:

• Reviewed design histories files (DHF), performed GAP analysis and prepared Remediation Plans to fix the gaps identified.
• Served as quality liaison for R&D and completed quality activities for Design Change and New Product Development.
• Supported process and design improvement initiatives that focus on design input, design output, design verification, design validation and design transfer activities.
• Developed validation documentation (Requirements; Design Specifications; Risk Assessment; IQ, OQ, PQ and Reports) for manufacturing processes, systems, and equipment.
• Reviewed test methods and design verification test plans.
• Performed protocols for design verification, design validation, and aging that met various ISO standards.
• Provided quality input to project design controls and Failure Modes Effects Analysis (FMEA).
• Supported continuing engineering and new product integration quality activities. Primary activities include: pFMEA generation, developing IQ/OQ/PQ process validation protocols, and reviewing validation reports. Sustaining engineering functions to include executing CAPA activities, supporting Supplier Quality initiatives, mitigating audit findings, supporting facility modifications, and integrating customer quality requirements with existing policies and procedures.
• Responsible for the development and execution of Master Validation Plans, Risk Assessments, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Summary Reports.
• Ensured that Qualification Protocols, and Summary Reports were consistent with Good Documentation Practices prior to and after execution.
• Involved in validation process coordination within cross functional departments such as Technical Operations, Engineering, Quality Assurance, and Regulatory affairs.
• Responsible for Creation, evaluation, and validation of product and process test methods.
• Wrote test methods for some existing work instructions and developed strategies to validate them
• Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Developed functional test methods for design verification, process characterization, process validation, and finished product.
• IQ of new test equipment and validation of new software.
• Planning, strategizing, and executing validation activities.
• In corporate FDA guidance and external standards into functional test methods and their validation.
• Responsible for maintaining Quality System Regulations including Document Control and Record Control.
• Developed documentation for all aspects of software validation including risk assessments, and quality and regulatory assessments.
• Worked with the SMEs and internal and external reviewers to identify gaps and mitigate the risks.
• Set up design and development process as per 21 CFR 820.30 & ISO13485 requirements.
• Performed assessments on previously validated process validation documents.