Engineer Quality

Mohammed Tanvir

Email: ******@*****.***, Contact: (619) - 446 6537

Summary

Successful, hands on Quality & Validation engineer and a leader with broad experience Manufacturing, Process/Test Method Validation in manufacturing of medical devices & pharmaceutical industry. Background encompasses technology and project management with proven track record in innovation, process optimization, validation and documentation of manufacturing processes, new product implementation, quality assurance engineering and FDA regulations. Recorded successes in developing and implementing strategies for validation and documentation of new processes..

Synopsis

oExpertise experience as Process Engineer, Quality Engineer, Quality Supervisor, Manufacturing Supervisor in the medical device domain.

oExtensive experience in Test Method Validation (Gage R&R, Inspection Method,Attribute Test Method, Compendium Method, Destructive Test Method, Non-Destructive Test Method, and Variable Test Method) for disposable medical devices.

oExpertise in product and process transfer, process development and process design. Highly skilled in project management.

oWrote, reviewed, and approved SOP (Standard Operating Procedure), Protocols, Final Reports, Master Validation Plan, and Production plan for quality assurance/product support. Assisted in preparation of IQ, OQ, and PQ protocols and writing summary reports. Expertise in Creating Master Validation Plan flow chart to synthesize activities and shorten project completion time.

oWorking experience in Class III Medical Devices manufacturing, leading product transfers, improving processes, equipment qualifications and process validations.

oThorough knowledge on QSR, GMP, Statistics, NC, Validations, IQ/OQ/PQs, DOE, FMEA, and ISO 13485.

oStrong knowledge in Quality Systems (CAPA, FMEA, Quality Audit, GMP).

oWork as a key leader for diverse manufacturing teams as large. Responsible for optimize resources utilization within different manufacturing areas. Monitor and control departmental key performance indicators.

oManage all quality operations. Supervise quality technician teams as large. Monitor and control internal and external quality issues. Support R&D new product initiatives.

Expertise

FDA 21 CFR Part 820 (QSR)/GMP, ISO 13485, VMP (IQ, OQ, PQ’S), CAPA Test Method Validation, Quality management, Application of Risk Management Tools and Techniques: Lean Process Improvement, FMEA and Root Cause Analysis, Accuracy, SPC, DOE, Fault Tree Analysis, Flowcharting, Quality Assurance, and Supply Chain Management, Proficient with MS Excel, Word, Project, PowerPoint, Visio, Minitab, Visual Basic, Outlook, Adobe Acrobat, Agile, SolidWorks

Work Experience

Biomet3i Inc, Palm Beach Gardens, FL

January 2015 – Present

Process Validation/Quality Engineer

oCore member of the validation team, developing new organizational standards for validation protocols for product and process and manufacturing procedures. Wrote and implemented equipment/process qualifications, validations and engineering reports.

oProcessed numerous engineering change orders coming from Production Supervisors to production floor workers dealing various levels of errors in the machining and assembly.

oTasked, Wrote and executed IQ/OQ/PQ Protocols and Reports to validate production of medical devices. Developed process variables (DOE) for products and processes, launched and completed IQ/OQ/PQ for validation. Authored, reviewed, and executed multiple Validation Plans, PFMECA, IQ, OQ, PQ, Summary Reports, and rewrote SOPs incorporating visual aids.

oPrepared, reviewed, executed, and summarized validation protocols (IQ, OQ, PQ) for medical device manufacturing facility and manufacturing equipment.

oHands on experience with inspection of fixtures and successfully wrote many Inspection sheets for various fixtures and tools for a new product development.

oPerformed Root Cause analysis and implemented Corrective and Preventative Actions (CAPA), for product and process related concerns. Performed CAPA (Corrective Action and Preventive Action) as well as overseen all aspects of the NCM (Non-Conforming Material).

oParticipated in design, process Risk Analysis meetings, and design Change Control meetings.

oCoordinated and provided technical support as an individual and as part of team for New Product introduction, product/process improvement projects, failure investigation of customer complaints (CAPA) and Material Review Board.

oWorked with validation team of Manufacturing and R&D Engineers, Operations and Customer Support to complete/document and maintained the Master Validation Plan.

oInvestigated and recorded process system gaps, validation and verification gaps. Propose remediation of quality system gaps. Revalidation of manufacturing processes to conform to 21 CFR Part 820, and ISO 13485.

oParticipated in MRB (Material Review Board) meeting to go over NCM and implement and corrective action as necessary. Compliant system support, remediation, investigation and closure.

oPerformed Root Cause analysis and implemented Corrective Actions and Preventive Actions for products and processes in Manufacturing and packaging operations.

oParticipated in design, process Risk Analysis meetings, and design Change Control meetings.

oWorked as individual and part of team member in implementation of Compliance Master Plan (CMP) for Production & Process Control (P&PC) and Purchasing & Supplier Management controls.

oPerformed successfully Engineering Study for a product to improve production and process capability and wrote over 20+ new control plans for product tooling.

Teleflex Medical Inc, Reading, PA

August 2013 – December 2015

Validation(Test Method)/Manufacturing Engineer

oActed as a key member in Quality Engineering activities in product and process design, including risk management review, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation projects.

oWrote, Reviewed and approved all design control risk management documents such as plans, hazard analyses, and design and process FMEAs, and reports.

oEnsured the use of appropriate statistical tools such as collection and summarized data, drawing of conclusions with confidence, determination of sample sizes, data distributions, identification of relationships between variables, reliability, design, analysis of experiments, and statistical decision making met Industry Standards and Teleflex procedures.

oReviewed and analyze in-process and finished product testing and inspection results to ensure the Validations met Teleflex and FDA policies. Analyzed product complaints to confirm complaints and determine root causes. Performed Product Failure Investigations, to determine possible and root cause, provided corrective and preventive actions and/or process improvement activities where needed. Discussed product non-conformances from the Hospitals and with Complaint Lab. Investigators to determine whether they were process related or user- patient related.

oSupported the manufacturing facilities by evaluating non-conformances and participating in NCBs to address issues. Reviewed product and process control methods documents to ensure that criteria for identifying critical control points are met.

oWrote, Reviewed and approved Engineering Change Orders and Engineering Change Records, Graphics, Product Development History documents, IQ, OQ, PQ etc. for accuracy and correctness.

oInitiated CAPA for Berman Angiographic Catheter per Teleflex policy, led and conducted investigation to determine root cause for bursting. Implemented corrective and preventive measures.

Bard Medical, Covington, GA

November 2012 - May 2013

Validation/Quality Engineer

oRepresented quality engineering on New Product Development and sustaining engineering teams across three franchises with responsibilities including but not limited to drafting testing protocols and reports, performing data analysis, writing risk assessments, validating new processes and equipment, developing and validating Test Methods, general design verification activities, packaging and sealing qualifications, and supplier qualification

oFamiliar with design controls and their application to differing project categories. Performed Post Launch and Post Market Surveillance research and prepared reports for risk file

oGenerated Process and Design FMEAs, Risk analysis memos, and Qualification protocols and reports as part of new product design and sustaining engineering project teams.

oUsed Stat graphics and Minitab statistical software to analyze and compare data using statistical tools such as confidence and reliability, capability, Gage and R&R.

oLed test method validation efforts to achieve compliance to corporate standard. Consulted with suppliers to ensure a swift solution to incoming quality issues

oAssisted suppliers with ISO 13485 compliance program development.

Education

Bachelors in Chemical Engineering, A&M University, Texas

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