Attended meeting and interviewed subject mater experts to gather information to develop technical
Developed process validation installation qualification, operational qualification and process qualification
protocols in Microsoft Word to meet FDA regulatory requirements from CFR part . Managed
execution, and implemented improvements to the process. Documented and summarized results of
process validation in subsequent reports.
Gathered data during the execution of process validation protocols and used Microsoft Excel to organize it
into charts and tables for analysis.
Championed engineering change orders from creation to implementation in Agile product lifecycle
management database to resolve deviations, meet customer expectations and release new products.
In Oracle, setup pull sequences for new items and updated quantities for existing items as part of
implementation for engineering change orders
Investigated and researched the role of optical elements to properly document cleaning, handling,
mounting and installation.
Created format for TQC work instructions to move assembly verification points upstream and reduce time
for Quality Control inspection.
Reduced assembly time from to . days by collaborating with Lean Manufacturing Engineer to lay out
production line and update documentation for continuous flow.
Researched the cost and resources required to implement three different software packages to streamline
the creation of assembly work instructions. Made a final recommendation with a price of $ compared
to initial estimate of $, to $,. After approval and purchase of the software, created a template
and wrote the technical procedure for producing work instructions with the software.
Participated in design for manufacturing reviews and worked with Quality Control Manager on PFMEAs.
Wrote deviations for one time custom features to meet customer requests.
Initiated, justified and implemented new equipment purchases for process implementation and new product
Lead a team of manufacturing associates in a project to convert process documents to the new TQC
Investigated and dispositioned nonconforming material. Worked with Supplier Quality Engineers to resolve
nonconforming issues with incoming and raw material.
Maintained manufacturing acceptance test failure database, in Microsoft Access, adding new input fields
Used Share Point to gather assembly issues and publish documents for new line.
Senior Technical Operations Technician
Member of technical operations staff supporting the production of medical devices: digital scanning
microscope, automated slide stainer and flow cytometers. Provided technical solutions for process related
issues and questions to keep production running smoothly.
Created and maintained revision controlled documentation in MS Power Point and Word, working with
Document Control in accordance with ISO standards. Worked with both R&D and Production to gather the
relevant information. Documentation included text with accompanying photos, drawings, screen captures
and solid models.
Edited documents to ensure their accuracy and completeness as well as working to improve the