Quality Engineer Manager

Jason Laramie Manager,Quality Engineer

**** **** ******** **. **** 60 . Mesa, AZ 85206 . 480-***-**** .

********@*****.***

Profile

Dynamic Quality Engineer Professional with adaptability across multiple

industries; the most recent have been healthcare services as well as

information technology and software development. Confident Leader with the

skillset for implementing Quality Management Systems. Innovative Problem

Solver possessing a wide range of methodologies, user centered

troubleshooting, and finding timely solutions to technical and logistical

problems. Talented Strategist with experience planning, aligning, and

continually improving policy and leveraging technology to achieve business

and operational goals. Strong Manager with excellent motivational skills

to build and sustain forward momentum, directing work efforts with cross-

functional teams, and people management issues. Trusted Advisor to

executive management and serve on management team.

Professional Experience

Manager, Quality Engineer March 2013 -

January 2015

Alere, Scottsdale, Arizona

Develops remote health monitoring solutions that leverages cloud technology

to securely connect healthcare practitioners and their patients.

Created and reviewed regulated documents associated with the design and

manufacture of medical device products such as SOPs, specifications,

testing protocols and reports, quality control and reliability plans, and

Corrective Action Preventive Action process.

Integral part of the Quality department with testing of system environments

prior to version releases to Production.

Understanding of Quality Management Systems such as ISO 9001, ISO 13485,

and FDA's 21 CFR Part 820

Developed verification and validation plans, test and sampling methods,

sample size determination and acceptance criteria.

Lead the team for support on the assessment and disposition of

nonconforming material, CAPA investigations and effectiveness.

Internal auditing to ensure the company was compliant and conforming to

standards set forth by the FDA and UL.

Owned the rework of the CAPA process to make the system more robust and

efficient

Managed various priorities and cross-functional employees for testing in

regards to resources, timing and analyzing output.

Software Development Life Cycle following Agile methodologies with manual

testing within black-box, integration testing, regression and non-

regression testing.

Created reports based on testing performed on software and would determine

when updates were validated and implemented properly into a production

environment.

Oversaw verification process with offshore team setting requirements and

validating results.

Achievements

Progressed from Jr. Quality Engineer to Manager, Quality Engineer.

Top candidate for traveling in regards to testing devices, installing

systems, and other QMS requirements.

Technologist/ Lead ELISA Technologist January 2011

- March 2013

TASC, Inc. Phoenix, Arizona

Laboratory contracted out by the Arizona Justice Courts to test the urine

of court appointed individuals for the use of illegal drugs.

Operated and maintained two Olympus AU2700 EIA (enzyme immunoassay)

analyzers including ongoing validations, troubleshooting

and maintenance.

ELISA (Enzyme-linked immunosorbent assay) method development and writing

Standards of Procedure to increase productivity and

efficiency of the laboratory.

Established rapid solutions to problems utilizing formal education,

judgment and research to ensure accuracy of daily productivity.

Achievements

Lead ELISA Technologist

Increase 2011-2012 revenue $369,000 by creating the procedure and protocol

for testing of a new synthetic drug.

Progressed from entry-level to now training and consulting fellow workers

and management.

Education

Bachelor of Science in Engineering, Materials Science and Engineering

Arizona State University, Tempe, Arizona

Graduated in May 2010

Certified Quality Engineer- Anticipated June 2015

Qualifications

Produce high quality results

Understanding of XML, Microsoft Suite, Swish, .NET, TDD

Easily adapt to a technical work environment

Assimilate new ideas translating them into productivity

Projects

Worked alongside employee of Boeing during capstone project using PZT

sensors for health monitoring of polymer-based composites.

Constructed a working array of screen-printed Organic Light Emitting

Diodes.

Professional Affiliations

American Society for Quality- 2012 to present

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