SUMMARY

• Eight years’ experience based in Medical, and Pharmaceutical field.
• Excellent use in various types of inspection equipment’s such as Downloadable Micrometers and Calipers, Optical Comparators, Coordinate Measuring Machine (CMM), MicroVu, INSTRON, Smart Scope, Calibrated Microscopes, Computerized support equipment’s and accurate Blueprint reading.
• Detail oriented person wif extensive knowledge of TQM, Six Sigma, LEAN Manufacturing and DFT systems.
• Strong Computer skills wif PC/MAC user, Word, Excel, PowerPoint, Windows Operating Systems (XP, UNIX/LINUX), Database: (SAP, APPLYSTART). Engineering tools (PSPICE, STATGRAPHICS, MINITAB.
• Experience wif ISO, EPA regulations, and major Titles of teh FDA regulation. Part 11 (Electronic records and signatures), Part 58, 210 & 211 CGMP in manufacturing, and Quality System Regulation (Part 820).
• Knowledge and experience wif ISO 13485, ISO 14971, ISO 14001, and ISO 9001.
• Experienced in teh use of SPC tools.
• Experience wif CAD Software (SolidWorks).
• Excellent Mechanical aptitude, communication, interpersonal skills and attention to details.
• Strong knowledge in GDT (Geometric Dimensioning and Tolerancing) and Metrology.
• Basic knowledge on principle and use of quantitative and qualitative measuring equipment’s such as HPLC, AA spectrometer, UV Visible spectrometer, GC - MS.

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential, Plymouth Minnesota

Responsibilities:

• Performed test methods validations on molded and machined components under engineering supervision.
• Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
• Trained technicians on operating, maintaining and calibrating laboratory equipment specific to job.
• Performed FAIs and inspection on incoming materials using measuring tools including CMM, Smart scope, and Instron to determine if components are made according to specification(s).
• Draft technical documentations including test results, procedures and reports; presented reports to team for review and suggestion(s).
• Supervised technicians on data collection procedures including GRR.
• Developed test fixtures needed to validate test methods.
• Analyze test data and provide recommendations regarding testing and test designs for approval by teh supervising engineer.
• Assisted in programming and designing Smart scope fixtures to halp inspect components faster wif high-level accuracy.
• Assisted in evaluating suppliers’ performance.
• Possessed great computer skills-word processing, database applications and spreadsheet in a network environment-SPC, as well as strong communication skills and good mechanical aptitude.
• Monitored CAPA and NCMR log records.
• Audited and monitored established quality system.
• Participated in external audit - FDA, and internal audits.
• Read and interpreted engineering drawings and specifications of components, assemblies and equipment’s.
• Analyzed test data using different statistical tools-calibration curve.
• Ensured products were developed in accordance wif applicable industry standards, regulatory requirements and customer requirements.
• Worked wif Engineers to write an IP (Inspection process) in a simplified form.
• Suggested ways of simplifying procedures or processes to make more understanding and easy to follow.
• Worked wif Engineers in developing test plans.
• Analyzed test data, using different statistical tools
• Performed electrical test such as Impedance, low and high voltage on medical device.
• Performed inspection using GDT methodology.
• Perform reliability test on ICDs such as thermal shock, shelf life testing.
• Perform pull test on anchor sleeves using INSTRON.
• Perform stress and fatigue test on leads (ICDs).
• Involved in keeping inventory records, scrap and ensuring daily yield is maintained.
• Performed duties to develop Process Control Plan (PCP)
• Evaluated and communicated quality status of products wif on-duty supervisors.
• Trained new hires on assembly production processes.
• Recorded and maintained test results as required by customers.
• Performed inspection and full procedural documentation of products.
• Inspected PC Board and provided troubleshooting
• Performed weekly maintenance on equipment.
• Maintained quality product and processes through defined inspection and test requirements.
• Perform data analysis usually using Statistical tools.

Assistant Project Manager

Confidential, Chicago, IL

Responsibilities:

• Gathers, analyzes, translates and delivers information in clear, concise and meaningful formats based on specific project and/or program requirements and according to established project management standards
• Perform departmental administrative duties: Ordering office supplies; Creating and maintaining forms; Assisting wif employee timekeeping and expense reports; Scheduling meetings and preparing meeting materials; Making travel arrangement.
• Preparing project documentation and sending out project communications.
• Involved in keeping inventory records, scrap and ensuring daily yield is maintained.
• On-boarding new employees including office set-up, arranging equipment and supplies, and coordinating training and badging.
• Electronic filing of project documents
• Project accounting and close-out
• Validation, write protocol and summary report
• Analytical Testing for quality control
• Evaluated and communicated quality status of products wif on-duty supervisors.
• Recorded and maintained test results as required by customers.
• Performed inspection and full procedural documentation of products.
• Maintained quality product and processes through defined inspection and test requirements.
• Facilitates collaborative documents and data stores and prepare status reports and presentations.
• Updating and maintaining input activities in project schedules
• Scheduling of project meetings.
• Assisting Senior Project Managers wif Projects.
• Help maintain project progress information.
• Manage project documentation, meeting schedules, agenda topics, schedules and drive accountability from project teams
• Develop relationships vendors and consultants.
• Experience wif tracking and reporting on specific projects and assumed deadlines.
• General understanding of various application development methodologies.
• Outstanding MS Office skills (Word, Excel, Access, Visio, Power Point and Outlook).
• Outstanding multi-tasker.
• Strong verbal and written communication.
• Strong conflict resolution skills.
• Experience working as a Project Coordinator.
• Experience wifin a Project Management Organization.
• Flexible and Adaptable
• Detail Oriented and resourceful problem solver.
• Excellent organization and time management skills.