Deanna Day Email & Phone Number

Austin, Texas Area

Austin, Texas Area

• Investigate defects found in customer complaints to determine true root cause based on understanding of the manufacturing equipment and processes.
• Initiate regulatory notification documents per current GMP standards.
• Ensure root cause, corrective and preventive action and overall product impact are thoroughly documented in investigations.
• Manage sister-site Supplier Corrective Action Request (SCAR) program and investigate defects related to commodities supplied by the Austin site.

Austin, Texas Area

• Investigate defects found in customer complaints to determine true root cause based on understanding of the manufacturing equipment and processes.
• Initiate regulatory notification documents per current GMP standards.
• Ensure root cause, corrective and preventive action and overall product impact are thoroughly documented in investigations.
• Manage sister-site Supplier Corrective Action Request (SCAR) program and investigate defects related to commodities supplied by the Austin site.

Austin, Texas Area

• Investigate defects found in customer complaints to determine true root cause based on understanding of the manufacturing equipment and processes.
• Initiate regulatory notification documents per current GMP standards.
• Ensure root cause, corrective and preventive action and overall product impact are thoroughly documented in investigations.
• Manage sister-site Supplier Corrective Action Request (SCAR) program and investigate defects related to commodities supplied by the Austin site.

Austin, Texas Area

• Provided Quality Engineering leadership as part of a cross-functional new product development team
• Provided documented objective evidence in support of 510k submissions.
• Analyzed sterilization dose audit data from contract sterilizers to verify compliance to gamma sterilization requirements and released reports for device history records.
• Worked with suppliers to develop validated manufacturing and inspection process controls for instruments and implants.
• Created risk management documentation (FMEA, Risk Management Plan) to aid in identifying critical features of new medical devices and instruments.

Austin, Texas Area

• Analyze new products for adoption into existing cleaning/sterilization process
• Transitioned the cleaning and redeployment process for re-usable medical devices to a new facility
• Lead validation activities of quality inspection equipment utilizing Gauge R&R and analyzing results with Minitab utilizing ANOVA methods.
• Investigate and verify corrective action for product complaints
• Created product validation protocols, executed testing and released reports.
• Developed and executed custom reliability (fatigue) bench testing for instruments.

Support the implementation of new products introduced to the manufacturing line through the development of assembly and testing procedures. This resulted in production and delivery of a quality product in a safe and repetitive manner.Train internal manufacturing and contract manufacturing personnel on new product/option builds.Adapted assembly and test.

Introduce and train personnel on company developed logistics database used to ship finished product to the customer.Manage logistics database to ensure required material removed during customer prep was listed on the shipping checklist. This resulted in higher quality and reduced non-conformances from the end customer.Develop and implement the discrepant.

Developed Test Methodology, Facilitation and Customer Preparation procedures to ensure manufacturing quality and repeatability.24-hour engineering support for 9 platforms and 28 configurable mega-modules. Accessible 24/7, spent time on the floor, interacted with planners and project managers, clarified customer specifications and met material needs..

Developed the test procedure redline process for Final Test Engineering resulting in improved accuracy and accountability for product/software changes.As Project Leader, coordinated team efforts during a final test time-study and effectively developed the team presentation at the conclusion of the project.Modified AutoCAD drawings to incorporate changes in.

Support students and professors in the usage of various word processing and publication Mac and PC applications.

Bsengtech, Engineering Technology

Activities and Societies: Society of Manufacturing Engineers - Student Chapter Minors in mathematics and psychology.

Continuing Education, Basic Shielded Metal Arc Welding/Oxyacetylene Welding/Mig Welding

Solar Pv System Design And Installation

An intensive 40-hour workshop based on the North American Board of Certified Energy Practitioners (NABCEP) task analysis in preparation.