SUMMARY

• Over 12 years’ experience in medical device (Class me, II and III), pharmaceutical and semi - conductor industries.
• Strong experience in addressing FDA’s 483 and Warning Letters and driving remediation efforts.
• Detailed oriented person with extensive knowledge in Six Sigma tools including DMAIC and DMADV.
• Strong experience in application of FDA regulation - Part 811 and 210 & 211, ISO 13485, ISO 14971, ISO 14001.
• Strong knowledge in GDT (Geometric Dimensioning and Tolerancing) and excelllent knowledge in teh use of SolidWorks.
• Strong knowledge in teh use of various statistical software including MINITAB.
• Strong use of database softwares such as Agile, Trackwise, EtQ, and IQMS.
• Strong communication skills both verbal and written - authored hundreds of documents - protocols, reports, test plans, engineering studies, and made several presentations before top managements, e.g. CAPA review meetings, Management team meetings.
• Strong computer skills - e.g. Microsoft Word, Excel and Powerpoint.
• Over 4 years experience in leadership/managerial experience - supervised entry level quality engineers, quality technicians, and quality inspectors.
• Strong project coordinator experience - for example, championed several CAPAs, lead site’s Master Validation Plan, and lead site’s Complaint Investigation team.
• Strong ability to work as a team - partipates in peer review approval process.
• Strong statistical knowledge - e.g. Descriptive statistics, SPC, DOE and ANOVA.
• Strong knowledge in use of risk assessment tools - e.g. FMEA, Fault Tree Analysis.
• Strong knowledge in quality audits - internal and supplier audits.
• Strong lean manufacturing experience.

PROFESSIONAL EXPERIENCE

Confidential, Warsaw, Indiana

Post-Market Surveillance Engineer

Responsibilities:

• Perform Product Complaint Evaluation (PCE) as part of Complaint Investigation; write and complete complaint reports and ensure timely closure.
• Perform Medical Device Reporting evaluation to determine if complaint should be reported to appropriate government agency.
• Perform complaint trending; initiate Issue Evaluation to determine if a CAPA should be opened.

Confidential, Minneapolis, Minnesota

Senior Quality Engineer

Responsibilities:

• Prepare pFMEA and update as necessary for product family.
• Lead failure analysis efforts and implement conclusions from these analyses.
• Write process validation (IQ, OQ, and PQ) protocols and test method protocols, supervise execution and prepare reports for peer review approval.
• Design tools and fixture to aid process and also inspection methods, validate these tools and fixture following internal procedure.
• Perform Process Characterization Study (PCS) on plastic injection molding processes to understand process input parameters and their TEMPeffects on process outputs.
• Design and validate test methods including writing test method validation (TMV) protocols, supervise TMV protocol execution, and prepare reports.
• Transfer processes and test methods from design to manufacturing, write and update manufacturing procedures (MP), and also provide training.
• Lead team Corrective and Preventive Action meetings, admistrate CAPA for product family.

Confidential, Minneapolis, Minnesota

Senior Quality Enginner

Responsibilities:

• Lead concurrent engineering team for process validation remediation effort for Intramuscular Stimulation Leads.
• Lead Product Development Review meetings for processes used in teh manufacture of Intramuscular Stimulation Leads.
• Write design verification protocols, supervise execution, and prepare reports.
• Write process validation (IQ, OQ and PQ) and test method protocols, monitor executions and prepare summary reports.
• Lead Master Validation Plan team.
• Write design verification protocols, supervise execution and prepare reports.
• Prepare and update Risk Management Plan (RMP) for product family.
• Prepare and update dFMEA for product family.
• Mentor and supervise quality engineers.

Confidential, Minneapolis, Minnesota

Senior Quality Engineer

Responsibilities:

• Coordinate and manage site’s Corrective Action and Preventive Action process.
• Lead site’s Customer Complaint team, prepare Complaint Investigation reports.
• Lead site’s internal audit program.
• Lead site’s validation team, manage Master Validation Plan, write process validation protocols and prepare reports.
• Perform Measurement System Analysis of measuring tools and equipment.
• Provide guidance to research and development group in developing test methods and processes in compliance with FDA and ISO.
• Develop and performed Supplier Qualification prior to adding suppliers to Approved Suppliers’ List (ASL).
• Scheduled and performed Suppliers’ Quality Audits, and manage Suppiers’ Non-Conformities from audits.
• Lead supplier management team with teh view to ensuring suppliers are in compliance with applicable regulatory standards, and actively engage suppliers in Root Cause Analysis, Statistical Process Control and Measurement System Analysis.
• Identify and assist in teh implementation of cost reduction initiatives.
• Prepare Microsoft Powerpoint presentation for site management team meetings, and show to teh team pertinent drives in teh site quality system.

Confidential, Jacksonsville, Minnesota

Senior Quality Engineer

Responsibilities:

• Perform design verification and qualification on molded and machined components assembly prior to product release.
• Write and update Risk Management Plan using ISO 14971.
• Interface with design engineers in identifying potential failure modes, dFMEA, recommending design changes as necessary.
• Implement Design for Assembly (DFA), Design for Manufacturability (DFM) and Design for Six Sigma to esnure prototypes were built with less waste and reduced Risk Index (RI).
• Monitor processes using Six Sigma techniques.
• Initiate Non-Conforming Material Review report to address failures in production line and using root cause analysis tools - such as fishborne diagram, to determine cause of failure and implementing appropriate actions.

Confidential, De Leon Springs, Florida

Quality Engineer

Responsibilities:

• Interface with other engineering team in teh development of new phase of Sonobouys
• Use design for assembly tools to address potential failure modes identified in dFMEA - ensuring Work Instructions (WI) are less subjective and less components to assemble.
• Use SPC tools to detect process variation and develop plans to address those variations.
• Use design for manufacturablity tools to mitigate risk and reduce cost when products are moved from design phase to production.
• Perform failure analysis (FA) to determine root cause and as necessary, use CAPA to drive those efforts.
• Perform measurement system analysis (Gage R&R) to understand teh accuracy of measuring devices and equipment.
• Write process validation protocols and prepare reports.

Confidential, Minneapolis, Minnesota

Quality Engineer

Responsibilities:

• Draft technical documentations incuding test results, procedures and reports.
• Develop test methods and process validation protocols/plans.
• Represent corporate and management findings of failure analysis (FA) and propose suggestion from FA for all Urology and Continence Care products.
• Develop test fixtures needed to validate test methods.
• Perform feasibility studies on penile implaints to verify capabilities and functionality.
• Perform risk assessment analysis using various tools including fault tree analysis (FTA).
• Coordinate with suppliers and external sources within teh company needed in developing and implementing new processes and product plans; ensure closure of SCARs issued to suppliers.
• Train and supervise technicians on operating, maintaining and calibrating laboratory equipment specfic to job roles.

Confidential, Minneapolis, Minnesota

Quality Engineer

Responsibilities:

• Evaluate product performance and safety prior to market release
• Provide support for released products, evaluate field performance and recommended corrective actions
• Perform measurement system analysis to understand teh error in measurement devices and equipment.
• Monitor process and event analysis results and propose additional actions needed including initiating CAPA and ensuring timely closure
• Prepare, review and approve Qualification Test Plan, (QTP), and reports for product family.
• Perform risk assessment and dFMEA for Implantable Cardioverter-defibrillators (ICDs) devices in compliance with FDA regulation and ISO 14971.
• Interface with design engineers to create and modify documentation, drawings, BOMs, ECOs to continously improve designs.
• Write complaint reports – complaints from teh field, generate MDR – if reportable, and use CAPA as necessary to drive product improvement or address failure mode identified in teh complaint.