SUMMARY

• Skilled engineering professional with expertise in Bio medical devices performing CAPA Remediation’s, DHF’s, GAP Assessments, Validation &Verification’s and Quality Assurance.
• Experience in a FDA and ISO regulated medical device industry.
• Experience with engineering design, design control in both engineering and manufacture departments.
• Hands on experience in projects involving Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
• Strong technical writing skills having written test protocols, technical reviews, presentations, SOPs, study reports, nonconformance’s investigative reports, V&V reports.
• Sound experience in preparation of Change Control Forms to implement the proposed alterations.
• Experience in creating and reviewing of Design History Files (DHF).
• Performed GAP analysis and remediation activities for a variety of medical devices documents.
• Expertise in problem solving techniques like Six - Sigma, Kaizen, 5 Whys, DMAIC.
• Strong skills with Risk Assessment, Corrective Action and Preventive Action (CAPA) investigation.
• Experience in risk management files such as PFMEA and DFMEA.
• Work independently to create process documentation including process flows, process inputs and outputs, process steps.
• Hand on experience with tools like Minitab, PRO- E, CATIA and SolidWorks and GD&T.
• Knowledgeable about GD&T, ISO standards, ASTM standards, FDA regulations, and 21 CFR Part 11 and 820 requirements.
• Experience with tools like Microsoft Power Points, Excel, Project Plan, Minitab, Pro-E, AutoCAD and SolidWorks.

PROFESSIONAL EXPERIENCE

Manufacturing Engineer

Confidential, Memphis, TN

Responsibilities:

• Prepare and update Inspection Method Records (IPRs), routers for Implants and instruments.
• Provide floor support for Inspection method records, GD&T issues in Blue prints, BOM Issues, and Supplier Inspection Issues.
• Support for Creating Standardization Work Instruction for efficient output for Packaging and Inspection Line.
• Create a Work order Routers for various operations using SAP.
• Disposition of NCRs related to Supplier Issues and Internal Issues Using Trackwise.
• Provides support on CAPA for high risk (Directly Impacted) issues.
• Performed Gap Analysis onDHF record and supported the DHF Remediation.
• Worked on test method development and validation (IQ/OQ/PQ) in compliance with FDA regulations, design of experiments, fixture design, production support, continues quality improvement.
• Provide a Sufficient Guidelines and support to inspectors to Measure a Feature of Implants, Case, and Instruments using CMM, Micrometer, Calipers, Go No Go gauges, comparator etc.
• Creates Inspection method records and MCO using Bill of materials (BOM), and Blue Prints.
• Provide support to R&D, manufacturing, marketing, and interface with suppliers.
• Plan and coordinate validation activities, cost saving proposals, test method improvements, diagnosis and problem solving via nonconforming material/root cause analysis and operations controls.

Validation Engineer

Confidential, Chicago, Illinois

Responsibilities:

• Reviewed SOP’s and followed the guidelines of the current GMP for the clean room environment provided by FDA
• Reviewed MEP (Mechanical, Electrical, Piping),Pressure flow, ISO classification, Floor diagram, and equipment diagram drawings
• Prepared IOQ protocols for Equipment’s, Facility, and Utilities according to 21 CFR Part 11 and cGMP Requirement.
• Prepared validation protocols for equipment, facility and performed Environmental Monitoring Performance Qualification.
• Updated the SOP’s of Environmental monitoring, Good documentation, cleaning or sanitization, Viable, Non-Viable monitoring, Gowning procedure, material and Personnel flow and related SOP’s of facility and Equipments.
• Updated and Created User Requirement specification of Equipments and facility (E.g. Laminar flow hood, Incubator, Bio reactor, Ultra filters, Refrigerator Bench Scales etc.)
• Executed the IQ and PQ protocols for Facility and Lab equipments.
• Developed PFMEA, and risk analysis documents for medical devices.
• Worked on temperature, Humidity, Air balancing, HEPA leak, Material of construction test.
• Creating and co-ordinates for approval of Change control for facility as well as equipments.

Validation Engineer

Confidential, Hauppauge, New York

Responsibilities:

• Mechanical test and documentation of new and existing products.
• Supported manufacturing by resolving engineering related problems in an expeditious manner in order to minimize disruptions to daily operations.
• Worked with a team to develop an implementation strategy to retrospectively create Design History Files per FDA 21 CFR 820for medical device products.
• Prepared IQ/OQ/PQ protocols for facility, Utilities, and manufacturing Equipment (Including grinding and mixing, Compression, Packaging department) according to 21 CFR Part 11 and cGMP Requirement.
• Performed product and process characterization and capability studies, DOE for process performance modeling, Statistical Process Control Implementation.
• Created flowcharts, explanatory documents and project plans and organize and execute gap analysis for DHF.
• Conducted weekly design reviews with the manufacturing and the cross-functional teams solving gaps in the remediated documents relevant to specific DHF’s.
• Performed testing, cleaning verification/validation swabbing, and review of QC results.
• Reviewed MEP (Mechanical, electrical, Piping, HVAC Drawing) drawings, test utilities, test documents and specifications for Facility protocol.

Quality Engineer

Confidential

Responsibilities:

• Checked and approved a documentation Trough Test validation method which ensures quality of product and measurers.
• Finding a Non-conformity using Root cause method.
• Checked And verified documentation of manufacturing process Quality through R & R Gauge and CAPA study
• Using cpk and ppk and normality test measures the process capability and defective rate.
• Participated in CAPA meetings and activities, helped to resolve quality issues, and wrote investigations for non-conformances (NC).
• Supported Engineering Project's activities from documentation and drawings to specifications and coordination of changes as well as deliverables through project's life cycle.
• Updated and verified Calibration reports of equipments.
• Reviewed CAPA files and assess adequacy based on defined evaluation criteria. Remediation Plan execution for CAPAs and SCARs
• Experience with root cause and some risk assessment tools (DMAIC, fishbone) via investigative work