TAMMY
EDUCATION:
BS, Civil Engineering, UND (2016)
BS, Environmental Engineering, WNU (2009)
Associates - Civil Engineering Technology, Penn Foster College (2004-2008)
ENGINEERING EXPERIENCE:
Sr. Quality Engineer
Ethicon, Johnson & Johnson (Contracted with BEPC), San Angelo, TX (12/2014 – Current)
"Medical device engineering and manufacturing company of Sutures"
Ensure Quality Systems to be compliant with 21 CFR 820, Parts 4, 211, and ISO 13485 Standards for a Class II Medical Device for combination products. Investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Other functions performed include:
• Project development: design changes, new product development
• Documentation Control: Engineer Change Order, Create, Review and Approval Specifications, FMEAs, BHRs
• Validations: Development of test method validation OQ/PQ (Lead: Protocols, test method, and Completion Report Validation
• FMEA: Risk Mgmt., fault tree analysis, DOE, root cause analysis
• Support and perform Quality Audits - Internal, External, FDA, BSI Regulatory Bodies
• Statistical inspection sampling plans review and creation
• Product Impact Assessments: Analyze and rationalize
• CAPAs, Nonconformances (NCs) & Observations: Lead CAPAs, Failure Investigations, root cause analysis
• Manufacturing Management Experience: Managed approximately five (50) manufacturing and quality technicians. Performed scheduling for manufacturing, including future projections. Produced production job orders, Revised Inventory Control Procedures: First In, First Out; Cost of raw materials, and services and implemented cost effective quantity order procedures/timelines. Presented to Management on daily basis.
Quality / Manufacturing Engineer
BiO2 Medical, Inc., Golden, CO (10/2010 – 5/2014)
"Medical device engineering and manufacturing company of Inferior Vena Cava Filter Catheters"
Development and implemented a full Quality Systems to be compliant with 21 CFR 820 and ISO 13485 for a Class II/III Medical Device for the purpose of CE Marketing for production of medical device designed to provide prophylactic Pulmonary Embolism (PE) protection in patients at high risk. Other functions performed include:
• Nonconformance (NCRs): Led Material Review Board (MRB) meetings to determine corrective action as necessary, data trend, and produce manufacturing yields for reporting to management review board. Increased yield 10 to 30% in multiple processes and inspection criteria. Worked with suppliers to find root-cause of defects.
• CAPA: Lead CAPAs, Failure Investigations, root cause analysis and implement corrective or corrective actions.
• Preventive Maintenance and Calibration System: Implemented new process leading to reduction in calibration cost to 40%.
• Regulatory audits (external, design and microbiological): Lead and co-led with zero major audit findings, which led to successful granting of ISO 13485 certification and CE mark certifications.
• Cleanroom Experience: Validated Cleanroom Class 8 (100,000) through IQ/OQ/PQ procedures using the ISO-14644 requirements. Performed continual microbial monitoring (Air, Surface, Floor) utilizing ISO-14644 and 14698. Reduced cost to Cleanroom expense at the same time reduced frequency of cleaning schedules, thus less cost to manufacturing and less downtime to manufacturing production.
• Validations: Developed and executed process and product validations performed on manufacturing (IQ/OQ/PQ). Performed design verification testing such as blood clot testing, bond strength tensile testing, and flow rate testing. Analyzed testing data through Jump (JMP) software and perform statistical analysis including technical report writing.
• Manufacturing Management Experience: Managed approximately five (5) manufacturing technicians. Performed scheduling for manufacturing, including future projections. Produced production job orders, Revised Inventory Control Procedures: First In, First Out; Cost of raw materials, and services and implemented cost effective quantity order procedures/timelines.
Jr. Civil Engineer
American Engineers and Surveyors Group, Parker, CO (2007-2009)
"Multidisciplinary engineering firm specializing in structural, civil, electrical, mechanical, and architectural designs for government, industrial and residential"
Provided civil engineering expertise as it relates to commercial, industrial, federal, state and government buildings for various projects. Other functions performed include:
• Designed structural drawings for custom homes including concrete foundations, walls, floors and roofs with calculated beam sizes and floor loads.
• Designed water/sewer basins, drainage, grading, storm water management and roadway layouts.
• Performed technical writing, design analysis and specification document writing for construction contract bidding of various industries ...
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