Quality Engineer Resume Ogden, UT - Hire IT People

PROFESSIONAL SUMMARY:

10+ years of Biomedical and Quality Engineering experience
Utah Resident Insurance License and 32 other states Licenses: California and Georgia State
Perform product engineering functions, interact with customers, conduct CAPA investigations and write reports on RMA medical disposables complaints on the following: Pumps, 2000, 4000, 6000 and Pain smart series, Ambulatory Infusion systems
Worked with vacuum systems and pumps, optics lasers, and alignment robots
Taught points in a clean room environment
Hands on experience on the following: caliper, gauges, micrometer, force gages, CMM and optical gauging machine.
Specifically tested high Voltage boards like injectors, saving the organization millions of dollars
Vast experience in the following: Quality Audit, FAI, FMEA, PPAP, ISO 1, ISO 9001, MDR - 21 CFR PART 803, ISO14971, Med watch and GMP-21 CFR PART 820
Evaluate current complaints trends and procedures, initiate CAPA investigation, and identify of the root causes of defects returns from the field
Serviced and installed systems at the following locations: Duke University, Tufts University, St. Barnabas Hospital, and Cleveland Clinic

SKILLS:

Perform product engineering functions, interact with customers, and conduct CAPA investigations and write reports on RMA medical disposables complaints on the following: Pumps, 2000, 4000, 6000 and Pain smart series, Ambulatory Infusion systems
Experience in Verification/Validation activities (IQ, OQ, PQ) test and inspection method development, PMP, Med watch, strong statistical skills and complete understanding of design and process controls, production and process controls, CAPA, complaints, root cause analysis, risk assessment and management, and quality improvement tools such as TQM, Six Sigma.
Worked with vacuum systems and pumps, optics lasers, and alignment robots
Vast In technology MS Office, MS project, Window, Gage R&R, Minitab and Excel
Specifically tested high Voltage boards like injectors, saving the organization millions of dollars
Evaluate current complaints trends and procedures, initiate CAPA investigation, identify of the root causes of defects returns from the field and conduct Complaint Product Investigation

PROFESSIONAL EXPERIENCE:

Confidential, Ogden, UT

Quality Engineer

Responsibilities:

Perform product engineering functions, interact with customers, and conduct CAPA investigations and write NCR, rework instruction and deviation reports on medical dialysis product complaints
Evaluate current complaints trends and procedures, initiate CAPA investigation, and identify of the root causes of defects returns from the field

Confidential, Salt Lake City, UT

Complaint Analyst Engineer

Responsibilities:

Perform product engineering functions, interact with customers, and conduct CAPA investigations and write reports on RMA medical disposables complaints on the following: Pumps, 2000, 4000, 6000 and Pain smart series, Ambulatory Infusion systems
Reviewed Adverse Events for MDR determinations and collected appropriate patient data as needed
Provide customer service with doctors and nurses in hospitals across the U. S. and globally
Troubleshoot and resolve medical devices problem in the field
Evaluate current complaints trends and procedures, initiate CAPA investigation, and identify of the root causes of defects in returns from the field

Confidential, Salt Lake City, UT

Field Service Engineer

Responsibilities:

Installed and troubleshot Microwave and RF Hyperthermia equipment used in cancer therapy
Hands-on experience with RF test equipment, including spectrum and network analyzers, power meters, oscilloscopes, and power supplies, and wave form generators , and also understand S-Parameters, and filter parameters
Serviced and installed systems at the following locations: Duke University, Tufts University, St. Barnabas Hospital, and Cleveland Clinic
Worked on Amplifier, RF with range of frequency 100MHZ to 915 MHZ and Ablation systems
Performed initial and final calibration on BSD 500 and Ablation systems before they were shipped to customers

Confidential, Santa Clara, CA

Field Service Engineer

Responsibilities:

Performed installation, preventive maintenance, repairs, and system calibration on semiconductor capital equipment globally
Worked with vacuum systems and pumps, optics lasers, and alignment robots
Taught points in a clean room environment
Troubleshot software and hardware problems with components, boards, and module levels.

Confidential, Concord, CA

Installation Service Engineer

Responsibilities:

Performed pre-test and system calibration on linear accelerators before they were installed
Troubleshot components, boards, and module levels
Tested RF drivers for the range of spectrum between 3 MHz to 5GHz
Specifically tested high Voltage boards like injectors, saving the organization millions of dollars