Danielle Marshall Email & Phone Number

Reno, Nevada, United States

- Manage all the Document Control aspects of the company- Manage all aspects of setting up company-wide training- Reviews, assesses and approves deviations and change controls- Reviewing and releasing of all records associated with internal and external manufactured product- Performing review of records (eg - CoA, CoC) and testing results

Reno, Nevada, United States

- Works with production of CO-RE tip department to ensure existing or new procedures are following the current regulations.- Performs internal, external, and in-process audits throughout the company. - Conducts and documents internal non-conformances, supplier non-conformances, customer complaint investigations, and corrective action reports.- Initiates, investigates, and/or manages Corrective/Preventative actions based on data review, audits, and input from outside sources.- Facilitates or assists with the completion of Risk Analysis documentation for new and existing products/processes- Reviews change orders for product releases/updates and production material and process changes.- Main quality contact for the CO-RE Tip department for any customer inquiries or audits.

Reno, Nevada Area

- Works with production of CO-RE tip department to ensure existing or new procedures are in compliance with the current regulations.- Performs internal and in-process audits throughout the company. - Conducts and documents internal non-conformances, supplier non-conformances, and customer complaint investigations.- Works with production personnel and manufacturing engineers to complete and approve product and process validation activities.- Reviews change orders for product releases/updates and production material and process changes.- Facilitates or assists with the completion of Risk Analysis documentation for new and existing products/processes.- Initiates and/or manages Corrective/Preventative actions based on data review, audits, and input from outside sources.- Serves as quality contact during customer and notified body audits for CO-RE Tip department.

Rochester, New York Area

● New Product Development & Validation- Process Development Functional Lead on team tasked with commercializing a new contact lens material. Responsibilities included:▪ Performing pilot and production scale experimentation to determine optimal process conditions. Analyzing experimental data and communicating results to key stakeholder. ▪ Updating multiple product and process specification documents in preparation of product validation.▪ Qualifying various steps in the high volume manufacturing lines.● Plant Manufacturing Support- Lead engineer tasked with determining root cause of defect seen in 5-20% of lenses, and implementing corrective actions. ▪ Authored and executed multiple engineering studies to determine root cause.▪ Rapidly identified location in process where defect occurred, and developed a modified process that reduced the incident rate to below 2%. ▪ Led effort to validate the modified process. ▪ Work in progress to drive the defect rate to 0%.

Rochester, New York Area

● New Product Development- Authored and executed protocols that produced lenses used in internal and external clinical evaluations. Documented results in accordance with FDA guidelines.- Authored Finished Product Specifications (FP) and Manufacturing Process Specifications (MP) for new contact lens product.● Development Lab Support- Utilized engineering change control processes to execute Installation/Operational Qualifications (IQ/OQ) for proof-of-concept automated equipment in the development lab.- Responsible for updating department Standard Operating Procedures (SOP). Led effort to create a Development Device Master Record (DDMR), which simplifies protocol creation and execution, and has improved accuracy and machine efficiency.● Plant Manufacturing Support- Investigated and validated second source components for lens material.- Assisted with completion of project technical package.- Created and executed experiments to test different parameters of a key process step, and developed optimized control specifications for the Manufacturing Process Specifications (MP) document. Analyzed data and presented developed recommendations to the team. Implemented findings resulted in a 15% reduction in material usage.

● New Product Development- Worked with members of other disciplines to create an improved cure process for an existing lens material.- Designed and performed experiments to explore different lens chemistries, mold materials and compare to the current material and competitors.- Responsible for database queries to retrieve key process data and interrogating the data with statistical software tools to create process control charts. Charts used to identify process issues and verify process specifications.- Authored experiments & technical reports testing shelf life of lens material and lens measurement performance capabilities.

Rochester, New York Area

• Provide support to Sports Information Directors at school athletic events.• Maintained and updated sports website and game-day rosters. • Observed, collected, and reported game day statistics. Loaded data into homegrown database.

Rochester, New York Area

● Worked with senior engineers to create new processes used to manufacture contact lenses. Responsible for optimizing the most technically complex portion of the manufacturing process. ● Created a template for authors to use when writing experiments. Template standardized experimental input and execution, which ensured compliance across operations. ● Generated and performed experiments focused on a critical part of the production line. Tested different hardware configurations and developed optimized process conditions. Collected and analyzed data, and presented recommendations to the team.

Andover, Ma

• Provided support to lead engineers in the area of product testing, component and material evaluation, process improvement and failure analysis.• Supported new product design on VI converter (DC-DC) chips. • Responsible for generation and analysis of test failure data. Presented results to lead engineering to determine root cause of failure.

Waikele, Hi

• Planned activities to educate and entertain the children. • Leader of a group of 15-20 five to seven year olds.• Summers Only.

Rochester, Ny

• No supervision required.• Ran cash register and stocked goods.