After the Natus Seattle facility was closed, I became a Supplier Quality Engineer in acknowledgement of the work I had already performed remediating Natus Seattle suppliers as a Quality Engineer. I helped re-evaluate the entire company-wide approved supplier list as part of a team supplier remediation project. I led selection and evaluation of new suppliers and re-evaluation of existing suppliers used by Natus business units throughout the US and Canada. I drove the completion of Supplier Corrective Action Requests (SCARs), typically owning 5-6 SCARs at any given time. I monitored supplier performance by maintaining the supplier scorecard for 2+ years, and led a cross-functional cross-site team that determined and followed up on actions to be taken with suppliers in response to the scorecard results. I served on a Material Review Board (MRB), reviewed non-conformance reports (NCRs), and reviewed non-conformance data for trends and escalation to SCAR.During my time as a Supplier Quality Engineer I also earned my ISO 13485:2016 Lead Auditor certification. I planned and executed audits of new or existing suppliers. I typically performed around 7 audits a year.

I was promoted to Quality Engineer in recognition of my performance as a Complaint Specialist and my professional experience. I participated in a number of remediation projects that were ongoing at Natus Seattle at the time. I represented Quality in Design History File (DHF) remediation of Natus newborn care products. I remediated Natus Seattle's approved supplier list by re-evaluating supplier files. I converted the Risk Management Files of Natus Denmark (Otometrics) products to be compliant with a new Quality Management System (QMS) conforming to ISO 14971. I led cross-functional Risk Management Review sessions when new potential risks were identified via complaints.Additionally, I handled day-to-day QA inspection issues such as investigating and writing impact assessments for calibrated equipment found to be out of specification.

I began my role as a QA Complaint Specialist by investigating medical device complaints and documenting those investigations using Agile PLM software. I helped clear a large backlog of complaints as part of a remediation project.I later transitioned to become the Seattle team's medical device reporting specialist. I evaluated complaints for whether they were reportable to regulatory agencies. I wrote and submitted medical device reports to e.g. FDA (through ESG) and Health Canada. I was responsible for managing my time and maintaining records to ensure that all required initial and supplemental reporting was submitted by the appropriate deadlines.

As a Biomedical Engineer at Ad-Tech Medical Instrument Corporation, I was primarily responsible for remediating and developing medical devices under compliance with FDA 21 CFR 820 and ISO 13485 quality system regulations. Ad-Tech manufactures electrodes and supporting accessories for use in the treatment of epilepsy. I wrote design inputs, created design specifications and manufacturing work instructions, planned and executed design verification studies, and developed risk management files using FMEA. A Design History File (DHF) remediation project I led resulted in an FDA 510(k) clearance.I planned and executed test method validations (gage R&R studies) and process validations (IQ/OQ/PQ), such as for ultrasonic cleaning. I performed first article inspections using a Keyence Image Dimension Measurement System which I programmed and operated. Additionally, I served as the Engineering representative on Ad-Tech's Complaint Investigation Team for over two years. I became involved in root cause analysis of recurring complaint issues, implementing solutions to recurring complaint issues, and updating risk analyses in response to complaint data.

Through careful observation, note-taking and discussion with manufacturing personnel, I completely revamped the work instructions pertaining to Ad-Tech's subdural electrode lines. I leveraged the product knowledge I gained and working relationships I fostered as an intern in my next position at Ad-Tech.