Creative and process improvement focused quality assurance professional seeking new opportunities to utilize excellent project management and problem-solving skills. I have great attention to detail, soft skills, organization and familiarity using multiple management systems and programs.
Experience
Pipeline Medical Technologies Inc.
Nov 2017 – Sep 2023
Santa Rosa, CA
Quality Manager
- Developed SOP/WI, implemented and managed an entirely new QMS system that met the needs of a startup company using timelines, functional plans, and project goals
- Provided Clinical and Regulatory support for FIH
- Produced test protocols and reports for Design Validation, Animal studies, and packaging validation
- Planned and facilitated the development of two CER facilities per ISO14644 requirements for the design, construction, validation and operation of cleanrooms using Project Management methodologies
- Utilized project planning skills to create teams for process improvement projects and auditing of systems as clinical product progressed
- Maintained Document Control & Records, Design Control, PM Calibration, CER testing and certification, NCR system, CAPA system, Training system, Internal Audit system
Osseon LLC
Aug 2016 – Nov 2017
Santa Rosa, CA
Senior Quality Coordinator
- Submitted annual CMS report to FDA and registered company and devices for state of CA and FDA
- Prepared, researched, and was involved in the Design Control process of Class I and II devices
- Supported R&D, Engineering, and Operations with collaboration on design, production, and problem-solving based on feedback collected from customers
- Performed interim Regulatory duties while managing the Quality department as the only quality representative for 3 months, during which 3 external audits were conducted
Osseon LLC
Sep 2015 – Aug 2016
Santa Rosa, CA
Quality Coordinator/ Document Control
- Issued and reviewed manufacturing Batch Records
- Handled complaints, including decontamination of devices, and MDR submissions
- Actively took part in process improvement with revision and creation of new procedures and documents, root cause analysis, and lean principles
- Maintained training records, provided company-wide training, and cross-trained in operations and RA duties
- Managed and reviewed NCMRs and CAPAs, maintained databases/logs/records and reviewed procedures and suppliers based on trend analysis
- Prepared for and conducted Internal and External Audits, taking part in 5 on-site audits as the Quality representative - Conducted supplier audits and assisted in the review and qualification of a new sterilizer
- Organized and presented Management Review
- Reviewed and released 1-10 documents daily
