Alexandra Leos-Gonzalez, MBA

Transitioned into a Quality System Manager role in November 2023 after I successfully built and launched the training program at Freenome for the entire company. Acted as a back-up for other QMS functions like Nonconformance, CAPA, and Document Control. Assisted in the implementation and launch of electronic QMS ComplianceQuest. Managed Training and Change Management full-time. Managed CCB (change control board) meeting weekly and had ad-hoc meetings as needed. Tracked change orders via the ComplianceQuest change order module to Assisted as needed with migration activities from electronic QMS ETQ to ComplianceQuest System. Assisted other QMS areas in the creation of their training material and procedures for use with ComplianceQuest. Assisted in Supplier Internal Audits as co-Auditor. Lead Supplier Internal Audit. System Administrator for ComplianceQuest and Greenlight Guru. Assisted with electronic QMS ComplianceQuest validation test activities as needed.

At Freenome I am tasked with building the Training program for the organization. I managed to bring training from 66% to 99%. Managed the migration of data for metrics from previous system ETQ. Assisted with system validation activities in a Salesforce based system ComplianceQuest. Created a training administrator guide. Assisted other QMS areas as a backup, Nonconformance, CAPA and Document Control. Created and launched the Training program for the entire organization. Created Training Metrics for the entire organization. Launched Training Requirements by departments, roles, and functions. Managed day to day activities for Training and Change Management. Created Training procedures for ComplianceQuest Training module. Wrote validation test scripts for the validation of the ComplianceQuest Training module.

At Nevro I am tasked with revamping Document Control. This includes helping align their newly opened manufacturing site in Costa Rica. Managed Document Control with one employee reporting to me. Collaborated with Training Administrator to manage revision updates and training requirements. Trained new hires to the Arena PLM system. Created training material for Arena Users. Assisted as a backup for the Document Control Specialist and Training Specialist as needed.

Currently I have been tasked to help build a corporate Document Control system for the organization. Also, we will have to look into our QMS system and see how we can have this system be the central location for other departments for their documents and processes. I took a title demotion for this organization because I believe in the product and was excited about making an impact in Headquarters.

Neato Robotics was a different industry than what I was used to. Going form medical device to robotics is different but I enjoyed the experience. Neato offered flexibility and an opportunity to work and learn something new and interesting. I managed Document Control activities as well as the PLM system Arena as the account administrator. Having this role gave me the opportunity to collaborate with different departments which allowed me to gain new perspectives on what drives each.

Manager of Corporate Document Control, I assisted all sites with Document Control activities as needed. My most notable accomplishment here so far was fully taking on the ISO 13485:2016 certification transition project for the Fremont, Ca. site and successfully getting the certification for the site. I also assisted some of our other sites updating and reviewing processes to have a successful ISO audit.

Owned the Document Control area which consisted of: assuring documents were in alignment with ISO 13485:2016 and FDA requirements before release. Creating, updating and managing all ERP updates to BOM's and parts. Assuring all documentation including lot history records, Change Orders, Standards and all other Document Control records were available in the electronic QMS to avoid having the records removed from Document Control. Controlled and maintained all Document Control logs. Assisted with CAPA's. Experienced with testing and launching hybrid QMS processes on the QMS for Document Control and other QMS functions. Overlooked the project for off-site storage of records ready for archive. Owned and maintained the Training program. Experienced with addressing auditors and FDA Inspectors with processes belonging to Document Control and the QMS as needed.

Invuity, Inc. is an up and coming start up located in San Francisco. The day to day operations vary as I have to wear many different hats at any given time of the day. My Document Control responsibilities vary from updating documents electronically to maintaining the integrity of multiple spreadsheets. Also, I am the lead in maintaining the entire company training compliant. The best thing about working at Invuity is the new challenges a new day can bring. I am also working on creating a Document Control Drive, and two databases.

Multitest was a change in field for me. Having much of my experience in the medical field, Multitest took me back to the beginings of my career; semiconductors. It was a great opportunity and experience for me.

At Abbott Laboratories I handled complaints via an Internet database. The product was Diabetes meters. Working with Customer Service and my collegues at Abbott made this job a good experience.

Completed my Bachelor's here with a 3.5 G.P.A.

Completed my Associates Degree with a 3.6 G.P.A.