*Jupiter Endovascular is a company spin-off from Neptune Medical, incorporated in 06-2024*- Providing product development quality engineering support for cardiovascular aspiration catheters, across multiple design phases.- Authoring and reviewing design control documentation, quality plans, manufacturing documentation, and technical investigation memorandums- Designated QE for multiple manufacturing lines and managing cleanroom environmental monitoring and qualification- Supported company's first ISO 13485 + EU MDR and Microbiology audits

- Key areas of activity include: nonconformance reports and guiding investigations as needed, equipment and approved supplier management, document change order (DCO) processes, reviewal of Lot History Records, and managing RI/IQC timeliness.- Initiated and currently leading monthly CAPA review board meetings to improve CAPA closure timeliness and focus- Generating annual reports to meet QMS requirements and assisting in gathering data for multiple quality metrics for management review

- Worked with CRQ (Clinical, Regulatory, and Quality) team to ensure company policies, internal QMS, and standard operating procedures are compliant with FDA regulations- Provided quality engineering support for design-controlled sustaining engineering projects, such as: integrating second source suppliers for critical components, firmware and/or hardware updates to existing top-level Class II devices, expansions to Class I "accessory" offerings, or modifications to existing requirements on established product lines- Conducted investigations of product returns and developed work instructions to guide future failure analysis investigations.- Supported internal process improvement and “Lunch and Learn” guidance for cross-functional groups regarding quality practices- Supported high criticality supplier audits and company's first MDSAP audit

- Provided Quality Engineering support for a variety of Class II and Class III medical device and drug-device combination projects- Supported Quality Assurance activities including Risk Management (FMEAs, Risk Management Plans, Component/Supplier Quality Protocols), NCMRs, Customer Complaints, and SCARs- Initiated and reviewed document change orders and routing through the electronic document management system, IFS- Collaborated with Product Development and Operations teams within company and with clients on quality related issues, continuous improvement, new product development, and manufacturing. - Provided support for other quality activities and initiatives, employee training/retraining, quality data collection, supplier management, and internal + customer audits- Oversee preventative maintenance on select equipment

• Provided online tutoring for all “100 Level” physics courses offered at Cal Poly through the Physics learning center. • Graded homework, quizzes, and midterms for General Physics III and College Physics III• Previously graded all calculus and non-calculus based general physics courses

• Performed Electronic Medical Records documentation for psychiatrists in an inpatient mental health facility, including psychiatric evaluations, medication orders, diagnostic reviews, and other documents• Underwent 10 weeks of classroom training on medical and psychiatric terminology, medications, and diagnoses, in addition to 5 weeks of floor training